{"id":8226,"date":"2025-10-15T08:12:43","date_gmt":"2025-10-15T08:12:43","guid":{"rendered":"https:\/\/kmslaser.com\/?p=8226"},"modified":"2025-10-19T12:53:56","modified_gmt":"2025-10-19T12:53:56","slug":"requiere-una-maquina-de-terapia-de-ondas-de-choque-validacion-o-pruebas-clinicas","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/es\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\/","title":{"rendered":"\u00bfRequiere una m\u00e1quina de terapia de ondas de choque validaci\u00f3n o pruebas cl\u00ednicas?"},"content":{"rendered":"<p><iframe data-testid=\"embed-iframe\" style=\"border-radius:12px\" src=\"https:\/\/open.spotify.com\/embed\/episode\/122tzn2VQRZ368BUMd4Uzw?utm_source=generator&amp;theme=0\" width=\"100%\" height=\"152\" frameborder=\"0\" allowfullscreen=\"\" allow=\"autoplay; clipboard-write; encrypted-media; fullscreen; picture-in-picture\" loading=\"lazy\"><\/iframe><\/p>\n<p style=\"float: right; margin-left: 15px; margin-bottom: 15px;\">\n  <img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/1technician-in-a-certified-lab-performing-iec-60601.jpg\" alt=\"Ingeniero de laboratorio prueba dispositivo de ondas de choque dentro de un entorno de sala limpia (ID#1)\" class=\"top-image-square\">\n<\/p>\n<p>Recibo esta pregunta en casi todas las consultas de mis clientes: \u00bfnecesitan estas m\u00e1quinas una validaci\u00f3n cl\u00ednica real antes de que los hospitales o cl\u00ednicas puedan usarlas? S\u00ed, lo hacen.<\/p>\n<p><strong>S\u00ed. Las m\u00e1quinas de terapia de ondas de choque son dispositivos m\u00e9dicos. La mayor\u00eda de los mercados requieren validaci\u00f3n cl\u00ednica y pruebas de seguridad antes de la venta o importaci\u00f3n. El dispositivo debe demostrar un rendimiento seguro, controles de riesgo documentados y evidencia cl\u00ednica cre\u00edble para las indicaciones declaradas.<\/strong><\/p>\n<p>Este art\u00edculo explica los tipos de pruebas comunes, qu\u00e9 certificaciones se aplican antes de la importaci\u00f3n, c\u00f3mo verificar las afirmaciones y qu\u00e9 espera la FDA. Utiliza un lenguaje sencillo para que los equipos puedan informar r\u00e1pidamente a las partes interesadas.<\/p>\n<h2>\u00bfQu\u00e9 pruebas cl\u00ednicas se requieren com\u00fanmente?<\/h2>\n<p>Siempre sugiero comenzar con un plan de pruebas que refleje la aprobaci\u00f3n que desea. Esto ahorra tiempo y retrabajo m\u00e1s adelante.<\/p>\n<p><strong>Los requisitos comunes incluyen pruebas de seguridad y rendimiento en banco, biocompatibilidad para piezas en contacto con el paciente, seguridad el\u00e9ctrica y EMC, validaci\u00f3n de software y evidencia cl\u00ednica para las indicaciones previstas. Se espera un seguimiento post-comercializaci\u00f3n despu\u00e9s del lanzamiento.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/2infographic-listing-core-test-types-iec-60601-saf.jpg\" alt=\"Lista de verificaci\u00f3n de cumplimiento m\u00e9dico que incluye IEC 60601 e ISO 10993 (ID#2)\" title=\"Est\u00e1ndares Regulatorios\" \/><\/p>\n<p>Un programa completo combina evidencia no cl\u00ednica y cl\u00ednica. Las pruebas de banco demuestran que el dispositivo alcanza los objetivos y se mantiene seguro. La evidencia cl\u00ednica muestra que los pacientes reales se benefician cuando los usuarios capacitados siguen las instrucciones.<\/p>\n<h3>Pruebas no cl\u00ednicas principales (t\u00edpicas)<\/h3>\n<ul>\n<li><strong>Seguridad el\u00e9ctrica y EMC:<\/strong> Pruebas para <a href=\"https:\/\/webstore.iec.ch\/publication\/2612\">IEC 60601-1<\/a> <sup><a href=\"#footnote-1\" id=\"ref-1\">1<\/a><\/sup> (seguridad b\u00e1sica) y <a href=\"https:\/\/en.wikipedia.org\/wiki\/IEC_60601#IEC_60601-1-2\">IEC 60601-1-2<\/a> <sup><a href=\"#footnote-2\" id=\"ref-2\">2<\/a><\/sup> (EMC), adem\u00e1s de las normas colaterales aplicables.<\/li>\n<li><strong>Rendimiento y calibraci\u00f3n:<\/strong> Verificaci\u00f3n de la densidad de flujo de energ\u00eda, precisi\u00f3n de frecuencia, precisi\u00f3n del recuento de pulsos y estabilidad en el ciclo de trabajo.<\/li>\n<li><strong>Mapeo de salida ac\u00fastica:<\/strong> Profundidad focal, perfil del haz y repetibilidad entre lotes; m\u00e9todos de calibraci\u00f3n trazables.<\/li>\n<li><strong>Biocompatibilidad (ISO 10993):<\/strong> Materiales para piezas en contacto con el paciente probados seg\u00fan <a href=\"https:\/\/www.fda.gov\/medical-devices\/general-biocompatibility-guidance-and-resources\/use-international-standard-iso-10993-1\">ISO 10993<\/a> <sup><a href=\"#footnote-3\" id=\"ref-3\">3<\/a><\/sup>.<\/li>\n<li><strong>Ingenier\u00eda de usabilidad:<\/strong> Validaci\u00f3n de factores humanos para <a href=\"https:\/\/webstore.iec.ch\/publication\/26873\">IEC 62366<\/a> <sup><a href=\"#footnote-4\" id=\"ref-4\">4<\/a><\/sup> para pantallas, flujo de trabajo, advertencias y bloqueos.<\/li>\n<li><strong>Gesti\u00f3n de riesgos:<\/strong> An\u00e1lisis de peligros y controles bajo <a href=\"https:\/\/www.iso.org\/standard\/72704.html\">ISO 14971<\/a> <sup><a href=\"#footnote-5\" id=\"ref-5\">5<\/a><\/sup>.<\/li>\n<\/ul>\n<h3>Evidencia cl\u00ednica (t\u00edpica)<\/h3>\n<ul>\n<li><strong>Evaluaci\u00f3n cl\u00ednica basada en literatura:<\/strong> Para indicaciones bien establecidas que utilizan dispositivos equivalentes con especificaciones t\u00e9cnicas y condiciones de uso coincidentes.<\/li>\n<li><strong>Estudio cl\u00ednico prospectivo:<\/strong> Cuando las afirmaciones son nuevas, los par\u00e1metros difieren o la literatura no es suficiente; puede ser aleatorizado o de cohorte controlada.<\/li>\n<li><strong>PMCF\/registro en el mundo real:<\/strong> Datos post-comercializaci\u00f3n que confirman el beneficio-riesgo en la pr\u00e1ctica habitual.<\/li>\n<\/ul>\n<h3>Tabla 1 \u2014 Tipos de prueba t\u00edpicos por objetivo<\/h3>\n<table>\n<thead>\n<tr>\n<th>Objetivo<\/th>\n<th>Prueba o documento com\u00fan<\/th>\n<th>Lo que buscan los revisores<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Demostrar seguridad el\u00e9ctrica<\/td>\n<td>Informe IEC 60601-1<\/td>\n<td>Resultados de aprobaci\u00f3n, laboratorio acreditado<\/td>\n<\/tr>\n<tr>\n<td>Controlar emisiones\/inmunidad<\/td>\n<td>Informe IEC 60601-1-2<\/td>\n<td>M\u00e1rgenes de inmunidad, registros de aprobaci\u00f3n\/fallo<\/td>\n<\/tr>\n<tr>\n<td>Verificar salida<\/td>\n<td>Pruebas de banco ac\u00fasticas\/energ\u00e9ticas<\/td>\n<td>Bandas de tolerancia, trazabilidad de la calibraci\u00f3n<\/td>\n<\/tr>\n<tr>\n<td>Materiales seguros<\/td>\n<td>Resumen de la ISO 10993<\/td>\n<td>Clasificaci\u00f3n de contacto, matriz de pruebas<\/td>\n<\/tr>\n<tr>\n<td>Reducir errores de uso<\/td>\n<td>Archivo IEC 62366<\/td>\n<td>Escenarios de validaci\u00f3n, mitigaciones<\/td>\n<\/tr>\n<tr>\n<td>Mostrar beneficio<\/td>\n<td>Evaluaci\u00f3n cl\u00ednica \/ estudio<\/td>\n<td>Poblaci\u00f3n, puntos finales, estad\u00edsticas, EAs<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Un alcance claro y criterios de aceptaci\u00f3n documentados son vitales. Los revisores se centran en la trazabilidad de los riesgos a las pruebas y a los resultados.<\/p>\n<h2>\u00bfSon obligatorias las certificaciones antes de la importaci\u00f3n?<\/h2>\n<p>Me piden una \u201clista corta\u201d de certificados requeridos antes de que salga la carga. Eso es sensato. La falta de papeleo en la aduana es costosa.<\/p>\n<p><strong>S\u00ed. La mayor\u00eda de las jurisdicciones requieren certificaciones o registros espec\u00edficos antes de la importaci\u00f3n y venta. Los art\u00edculos t\u00edpicos incluyen el marcado CE bajo el MDR de la UE para Europa, la lista\/aprobaci\u00f3n de dispositivos de la FDA para los EE. UU. y registros espec\u00edficos de cada pa\u00eds en otros lugares. Los informes de seguridad (IEC 60601) y los res\u00famenes de pruebas deben respaldar la reclamaci\u00f3n.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/3flat-lay-photo-of-customs-documents-ce-certificat.jpg\" alt=\"Documentaci\u00f3n t\u00e9cnica CE y formularios de cumplimiento de la UE en portapapeles (ID#3)\" title=\"Documentos de Certificaci\u00f3n CE\" \/><\/p>\n<p>Para Europa, los fabricantes compilan la Documentaci\u00f3n T\u00e9cnica y un Informe de Evaluaci\u00f3n Cl\u00ednica para obtener <strong>marcado CE bajo <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\">MDR UE 2017\/745<\/a><\/strong> <sup><a href=\"#footnote-6\" id=\"ref-6\">6<\/a><\/sup>. En los EE. UU., la mayor\u00eda de los modelos terap\u00e9uticos pasan por el <strong>FDA <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm\">programa 510(k)<\/a><\/strong> <sup><a href=\"#footnote-7\" id=\"ref-7\">7<\/a><\/sup> antes de la comercializaci\u00f3n.<\/p>\n<h3>Tabla 2 \u2014 Instant\u00e1nea de preparaci\u00f3n para la importaci\u00f3n<\/h3>\n<table>\n<thead>\n<tr>\n<th>Mercado<\/th>\n<th>Imprescindibles antes de la importaci\u00f3n<\/th>\n<th>Clase de dispositivo t\u00edpica<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>UE\/EEE<\/td>\n<td>CE seg\u00fan MDR + certificado NB<\/td>\n<td>IIa\/IIb<\/td>\n<\/tr>\n<tr>\n<td>EE. UU.<\/td>\n<td>510(k) o de novo + listado<\/td>\n<td>II<\/td>\n<\/tr>\n<tr>\n<td>Reino Unido<\/td>\n<td>UKCA o CE aceptado + registro MHRA<\/td>\n<td>IIa\/IIb<\/td>\n<\/tr>\n<tr>\n<td>Canad\u00e1<\/td>\n<td>MDL + MDSAP<\/td>\n<td>II<\/td>\n<\/tr>\n<tr>\n<td>Australia<\/td>\n<td>Inclusi\u00f3n en ARTG<\/td>\n<td>IIa\/IIb<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Si un dispositivo se env\u00eda sin estos, la aduana o los reguladores pueden retenerlo, multarlo o exigir su reexportaci\u00f3n. Los distribuidores deben verificar los certificados con las bases de datos p\u00fablicas cuando est\u00e9n disponibles.<\/p>\n<h2>\u00bfC\u00f3mo verificar los informes de validaci\u00f3n cl\u00ednica?<\/h2>\n<p>A menudo me preguntan: \u201c\u00bfC\u00f3mo podemos saber si el archivo cl\u00ednico es real y relevante?\u201d Una lista de verificaci\u00f3n simple y neutral ayuda a ambas partes.<\/p>\n<p><strong>La verificaci\u00f3n significa comprobar la autenticidad, la relevancia y la trazabilidad. Los compradores deben confirmar laboratorios de pruebas acreditados, identidad de dispositivo consistente, indicaciones coincidentes y datos completos. La literatura independiente debe respaldar los mismos par\u00e1metros.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/4infographic-showing-verification-workflow-identif.jpg\" alt=\"Infograf\u00eda de lista de verificaci\u00f3n que muestra el proceso de aprobaci\u00f3n de dispositivos m\u00e9dicos (ID#4)\" title=\"Flujo de Trabajo de Aprobaci\u00f3n\" \/><\/p>\n<p>Confirme el alcance de acreditaci\u00f3n del laboratorio de pruebas para <strong><a href=\"https:\/\/www.iso.org\/standard\/66912.html\">ISO\/IEC 17025<\/a><\/strong> <sup><a href=\"#footnote-8\" id=\"ref-8\">8<\/a><\/sup>, y valide el n\u00famero del Organismo Notificado en la UE a trav\u00e9s de la <strong><a href=\"https:\/\/webgate.ec.europa.eu\/nando\/\">Base de datos NANDO<\/a><\/strong> <sup><a href=\"#footnote-9\" id=\"ref-9\">9<\/a><\/sup>.<\/p>\n<h3>Un flujo de trabajo de verificaci\u00f3n pr\u00e1ctico<\/h3>\n<ol>\n<li>Identifique el dispositivo claramente: haga coincidir el nombre comercial, el modelo, la versi\u00f3n de hardware y la compilaci\u00f3n de software en todos los documentos.<\/li>\n<li>Verifique la credibilidad del laboratorio: acreditaci\u00f3n y ediciones est\u00e1ndar correctas en los informes.<\/li>\n<li>Mapee los riesgos a las pruebas: alinee los peligros de ISO 14971 con la evidencia de verificaci\u00f3n\/validaci\u00f3n.<\/li>\n<li>Valide la relevancia cl\u00ednica: confirme la equivalencia de los rangos de salida, el tipo de onda y la poblaci\u00f3n de pacientes.<\/li>\n<li>Confirme la frescura de los datos: se hace referencia a la generaci\u00f3n actual de firmware\/pieza de mano.<\/li>\n<li>Verifique las declaraciones: DoC, certificados de NB o res\u00famenes de 510(k) enumeran el mismo modelo e indicaciones.<\/li>\n<\/ol>\n<h2>\u00bfLas normas de la FDA exigen pruebas cl\u00ednicas?<\/h2>\n<p>A menudo me preguntan: \u201c\u00bfLa FDA siempre nos obligar\u00e1 a realizar nuevos ensayos cl\u00ednicos?\u201d La respuesta depende del dispositivo, la indicaci\u00f3n y el predicado.<\/p>\n<p><strong>Para muchas m\u00e1quinas de terapia de ondas de choque, la v\u00eda de la FDA es 510(k). Es posible que se requieran o no datos cl\u00ednicos. Si el dispositivo coincide con un predicado en tecnolog\u00eda e indicaciones, la evidencia de laboratorio y bibliogr\u00e1fica puede ser suficiente. Si las afirmaciones o la tecnolog\u00eda son novedosas, a menudo se requieren estudios cl\u00ednicos.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/5flat-lay-photo-of-fda-clearance-letter-510-k-app.jpg\" alt=\"Documento FDA 510(k) junto a dispositivo m\u00e9dico aprobado (ID#5)\" title=\"Aprobaci\u00f3n de la FDA\" \/><\/p>\n<p>Para minimizar la incertidumbre, los equipos a menudo solicitan una <strong><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/q-submissions-program\">Q-Submission (Pre-Sub)<\/a><\/strong> reuni\u00f3n con los revisores de la FDA para alinear las expectativas de evidencia <sup><a href=\"#footnote-10\" id=\"ref-10\">10<\/a><\/sup>.<\/p>\n<h3>Tabla 3 \u2014 Cu\u00e1ndo la FDA a menudo espera datos cl\u00ednicos<\/h3>\n<table>\n<thead>\n<tr>\n<th>Situaci\u00f3n<\/th>\n<th>Probabilidad de necesidad de datos cl\u00ednicos<\/th>\n<th>Notas<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Misma tecnolog\u00eda + misma indicaci\u00f3n que el predicado<\/td>\n<td>Bajo<\/td>\n<td>Una s\u00f3lida evidencia de laboratorio + bibliogr\u00e1fica puede ser suficiente<\/td>\n<\/tr>\n<tr>\n<td>Nueva indicaci\u00f3n, misma tecnolog\u00eda<\/td>\n<td>Medio<\/td>\n<td>Evidencia cl\u00ednica dirigida probable<\/td>\n<\/tr>\n<tr>\n<td>Nuevas caracter\u00edsticas tecnol\u00f3gicas (por ejemplo, modalidad combinada)<\/td>\n<td>Alto<\/td>\n<td>Trabajo cl\u00ednico + trabajo de laboratorio extendido<\/td>\n<\/tr>\n<tr>\n<td>Reclamaciones de superioridad ampliadas<\/td>\n<td>Alto<\/td>\n<td>Datos comparativos prospectivos<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2>Conclusi\u00f3n<\/h2>\n<p>S\u00ed, la validaci\u00f3n cl\u00ednica importa. Planifique pruebas de laboratorio, est\u00e1ndares de seguridad y la evidencia adecuada para el mercado elegido. Verifique los informes cuidadosamente, alinee las reclamaciones con las aprobaciones y utilice la retroalimentaci\u00f3n temprana de la FDA o del Organismo Notificado para mantenerse encaminado.<\/p>\n<hr \/>\n<h2>Notas al pie<\/h2>\n<p><span id=\"footnote-1\">1. IEC 60601-1 \u2014 Norma b\u00e1sica de seguridad el\u00e9ctrica\/mec\u00e1nica para dispositivos m\u00e9dicos. <a href=\"#ref-1\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-2\">2. IEC 60601-1-2 \u2014 Requisitos y pruebas de compatibilidad electromagn\u00e9tica. <a href=\"#ref-2\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-3\">3. ISO 10993 \u2014 Marco reconocido por la FDA para la evaluaci\u00f3n de biocompatibilidad. <a href=\"#ref-3\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-4\">4. IEC 62366 \u2014 Ingenier\u00eda de usabilidad para reducir los riesgos relacionados con el uso. <a href=\"#ref-4\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-5\">5. ISO 14971 \u2014 Proceso de gesti\u00f3n de riesgos para dispositivos m\u00e9dicos. <a href=\"#ref-5\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-6\">6. EU MDR 2017\/745 \u2014 Base legal para el marcado CE y la evaluaci\u00f3n cl\u00ednica. <a href=\"#ref-6\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-7\">7. FDA 510(k) \u2014 Base de datos para verificar las autorizaciones de equivalencia sustancial. <a href=\"#ref-7\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-8\">8. ISO\/IEC 17025 \u2014 Acreditaci\u00f3n para la competencia de laboratorios de pruebas\/calibraci\u00f3n. <a href=\"#ref-8\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-9\">9. NANDO \u2014 Directorio de la UE para verificar Organismos Notificados y sus alcances. <a href=\"#ref-9\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-10\">10. FDA Q-Submission \u2014 Proceso para obtener retroalimentaci\u00f3n previa a la comercializaci\u00f3n sobre planes de evidencia. <a href=\"#ref-10\">\u21a9\ufe0e<\/a><\/span>  <\/p>","protected":false},"excerpt":{"rendered":"<p>I get this question in almost every inquiry from the my customers: do these machines need real clinical validation before hospitals or clinics can use them? Yes, they do. Yes. Shockwave therapy machines are medical devices. Most markets require clinical validation and safety testing before sale or import. The device must show safe performance, documented [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":8228,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[60],"tags":[],"class_list":["post-8226","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-shockwave-therapy-machine"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Does a Shockwave Therapy Machine require clinical validation or testing? - KMSLaser<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/kmslaser.com\/es\/requiere-una-maquina-de-terapia-de-ondas-de-choque-validacion-o-pruebas-clinicas\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Does a Shockwave Therapy Machine require clinical validation or testing?\" \/>\n<meta property=\"og:description\" content=\"I get this question in almost every inquiry from the my customers: do these machines need real clinical validation before hospitals or clinics can use them? Yes, they do. Yes. Shockwave therapy machines are medical devices. Most markets require clinical validation and safety testing before sale or import. The device must show safe performance, documented [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/kmslaser.com\/es\/requiere-una-maquina-de-terapia-de-ondas-de-choque-validacion-o-pruebas-clinicas\/\" \/>\n<meta property=\"og:site_name\" content=\"KMSLaser\" \/>\n<meta property=\"article:published_time\" content=\"2025-10-15T08:12:43+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-10-19T12:53:56+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/5flat-lay-photo-of-fda-clearance-letter-510-k-app.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"600\" \/>\n\t<meta property=\"og:image:height\" content=\"400\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Sophia Wu\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Sophia Wu\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\\\/\"},\"author\":{\"name\":\"Sophia Wu\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#\\\/schema\\\/person\\\/c37fe1d989e6bd9dbe4f1f7b6cfa9588\"},\"headline\":\"Does a Shockwave Therapy Machine require clinical validation or testing?\",\"datePublished\":\"2025-10-15T08:12:43+00:00\",\"dateModified\":\"2025-10-19T12:53:56+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\\\/\"},\"wordCount\":1018,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/kmslaser.com\\\/wp-content\\\/uploads\\\/2025\\\/10\\\/5flat-lay-photo-of-fda-clearance-letter-510-k-app.jpg\",\"articleSection\":[\"Shockwave Therapy Machine\"],\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/kmslaser.com\\\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\\\/\",\"url\":\"https:\\\/\\\/kmslaser.com\\\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\\\/\",\"name\":\"Does a Shockwave Therapy Machine require clinical validation or testing? - KMSLaser\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/kmslaser.com\\\/wp-content\\\/uploads\\\/2025\\\/10\\\/5flat-lay-photo-of-fda-clearance-letter-510-k-app.jpg\",\"datePublished\":\"2025-10-15T08:12:43+00:00\",\"dateModified\":\"2025-10-19T12:53:56+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\\\/#breadcrumb\"},\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/kmslaser.com\\\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\\\/#primaryimage\",\"url\":\"https:\\\/\\\/kmslaser.com\\\/wp-content\\\/uploads\\\/2025\\\/10\\\/5flat-lay-photo-of-fda-clearance-letter-510-k-app.jpg\",\"contentUrl\":\"https:\\\/\\\/kmslaser.com\\\/wp-content\\\/uploads\\\/2025\\\/10\\\/5flat-lay-photo-of-fda-clearance-letter-510-k-app.jpg\",\"width\":600,\"height\":400},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/kmslaser.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Does a Shockwave Therapy Machine require clinical validation or testing?\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#website\",\"url\":\"https:\\\/\\\/kmslaser.com\\\/\",\"name\":\"KMSLaser\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/kmslaser.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#organization\",\"name\":\"KMSLaser\",\"url\":\"https:\\\/\\\/kmslaser.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/kmslaser.com\\\/wp-content\\\/uploads\\\/2020\\\/02\\\/logo.png\",\"contentUrl\":\"https:\\\/\\\/kmslaser.com\\\/wp-content\\\/uploads\\\/2020\\\/02\\\/logo.png\",\"width\":180,\"height\":71,\"caption\":\"KMSLaser\"},\"image\":{\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/kmslaser.com\\\/#\\\/schema\\\/person\\\/c37fe1d989e6bd9dbe4f1f7b6cfa9588\",\"name\":\"Sophia Wu\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/c9ef0ccfb314c8803023560c97cab787692ab7de1e607e67d9eb308b91561b84?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/c9ef0ccfb314c8803023560c97cab787692ab7de1e607e67d9eb308b91561b84?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/c9ef0ccfb314c8803023560c97cab787692ab7de1e607e67d9eb308b91561b84?s=96&d=mm&r=g\",\"caption\":\"Sophia Wu\"},\"url\":\"https:\\\/\\\/kmslaser.com\\\/es\\\/author\\\/sophia\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"\u00bfRequiere una m\u00e1quina de terapia de ondas de choque validaci\u00f3n o pruebas cl\u00ednicas? - KMSLaser","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/kmslaser.com\/es\/requiere-una-maquina-de-terapia-de-ondas-de-choque-validacion-o-pruebas-clinicas\/","og_locale":"es_MX","og_type":"article","og_title":"Does a Shockwave Therapy Machine require clinical validation or testing?","og_description":"I get this question in almost every inquiry from the my customers: do these machines need real clinical validation before hospitals or clinics can use them? Yes, they do. Yes. Shockwave therapy machines are medical devices. Most markets require clinical validation and safety testing before sale or import. The device must show safe performance, documented [&hellip;]","og_url":"https:\/\/kmslaser.com\/es\/requiere-una-maquina-de-terapia-de-ondas-de-choque-validacion-o-pruebas-clinicas\/","og_site_name":"KMSLaser","article_published_time":"2025-10-15T08:12:43+00:00","article_modified_time":"2025-10-19T12:53:56+00:00","og_image":[{"width":600,"height":400,"url":"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/5flat-lay-photo-of-fda-clearance-letter-510-k-app.jpg","type":"image\/jpeg"}],"author":"Sophia Wu","twitter_card":"summary_large_image","twitter_misc":{"Escrito por":"Sophia Wu","Tiempo de lectura":"6 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/kmslaser.com\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\/#article","isPartOf":{"@id":"https:\/\/kmslaser.com\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\/"},"author":{"name":"Sophia Wu","@id":"https:\/\/kmslaser.com\/#\/schema\/person\/c37fe1d989e6bd9dbe4f1f7b6cfa9588"},"headline":"Does a Shockwave Therapy Machine require clinical validation or testing?","datePublished":"2025-10-15T08:12:43+00:00","dateModified":"2025-10-19T12:53:56+00:00","mainEntityOfPage":{"@id":"https:\/\/kmslaser.com\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\/"},"wordCount":1018,"commentCount":0,"publisher":{"@id":"https:\/\/kmslaser.com\/#organization"},"image":{"@id":"https:\/\/kmslaser.com\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\/#primaryimage"},"thumbnailUrl":"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/5flat-lay-photo-of-fda-clearance-letter-510-k-app.jpg","articleSection":["Shockwave Therapy Machine"],"inLanguage":"es","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/kmslaser.com\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/kmslaser.com\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\/","url":"https:\/\/kmslaser.com\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\/","name":"\u00bfRequiere una m\u00e1quina de terapia de ondas de choque validaci\u00f3n o pruebas cl\u00ednicas? - KMSLaser","isPartOf":{"@id":"https:\/\/kmslaser.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/kmslaser.com\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\/#primaryimage"},"image":{"@id":"https:\/\/kmslaser.com\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\/#primaryimage"},"thumbnailUrl":"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/5flat-lay-photo-of-fda-clearance-letter-510-k-app.jpg","datePublished":"2025-10-15T08:12:43+00:00","dateModified":"2025-10-19T12:53:56+00:00","breadcrumb":{"@id":"https:\/\/kmslaser.com\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\/#breadcrumb"},"inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/kmslaser.com\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/kmslaser.com\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\/#primaryimage","url":"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/5flat-lay-photo-of-fda-clearance-letter-510-k-app.jpg","contentUrl":"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/5flat-lay-photo-of-fda-clearance-letter-510-k-app.jpg","width":600,"height":400},{"@type":"BreadcrumbList","@id":"https:\/\/kmslaser.com\/does-a-shockwave-therapy-machine-require-clinical-validation-or-testing\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/kmslaser.com\/"},{"@type":"ListItem","position":2,"name":"Does a Shockwave Therapy Machine require clinical validation or testing?"}]},{"@type":"WebSite","@id":"https:\/\/kmslaser.com\/#website","url":"https:\/\/kmslaser.com\/","name":"KMSLaser","description":"","publisher":{"@id":"https:\/\/kmslaser.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/kmslaser.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":"Organization","@id":"https:\/\/kmslaser.com\/#organization","name":"KMSLaser","url":"https:\/\/kmslaser.com\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/kmslaser.com\/#\/schema\/logo\/image\/","url":"https:\/\/kmslaser.com\/wp-content\/uploads\/2020\/02\/logo.png","contentUrl":"https:\/\/kmslaser.com\/wp-content\/uploads\/2020\/02\/logo.png","width":180,"height":71,"caption":"KMSLaser"},"image":{"@id":"https:\/\/kmslaser.com\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/kmslaser.com\/#\/schema\/person\/c37fe1d989e6bd9dbe4f1f7b6cfa9588","name":"Sophia Wu","image":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/secure.gravatar.com\/avatar\/c9ef0ccfb314c8803023560c97cab787692ab7de1e607e67d9eb308b91561b84?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/c9ef0ccfb314c8803023560c97cab787692ab7de1e607e67d9eb308b91561b84?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/c9ef0ccfb314c8803023560c97cab787692ab7de1e607e67d9eb308b91561b84?s=96&d=mm&r=g","caption":"Sophia Wu"},"url":"https:\/\/kmslaser.com\/es\/author\/sophia\/"}]}},"_links":{"self":[{"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/posts\/8226","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/comments?post=8226"}],"version-history":[{"count":0,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/posts\/8226\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/media\/8228"}],"wp:attachment":[{"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/media?parent=8226"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/categories?post=8226"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kmslaser.com\/es\/wp-json\/wp\/v2\/tags?post=8226"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}