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Revisamos 10000 resultados en vivo para medical device ce marking and iso 13485 certification y los redujimos a 3 opciones que parecen valer más la pena comparar primero.
Los temas más fuertes en esta lista son Quality Management y Certification.
Fuente: Kiwa Portugal
Descripción
Targeted support for obtaining the CE mark under the Medical Device Regulation (MDR). This service includes auditing for ISO 13485 certification and detailed technical documentation reviews to ensure all European market access criteria are met for various medical device classes.
Ideal para
CE marking support, Technical file audits, Quality assurance y Regulatory compliance
Valoración
Fuente: DQS South Africa
Descripción
Specialized SANAS-accredited certification for ISO 13485, tailored for the medical device industry in South Africa. They also provide auditing for ISO 9001, ISO 14001, and ISO 45001.
Ideal para
Medical device manufacturers, Healthcare suppliers, Management system auditing y SANAS accredited certification
Valoración
Fuente: EMKI-cert Kft.
Descripción
Specialized certification and conformity assessment services for medical device manufacturers, ensuring compliance with EU regulations and the EN ISO 13485 standard.
Ideal para
Medical device manufacturers, EN ISO 13485 compliance, EU medical regulations y Healthcare industry quality
Valoración
| Comparar | Medical Device CE Marking and ISO 13485 Certification | ISO 13485 Medical Device Certification | EN ISO 13485:2016 Medical Device Certification |
|---|---|---|---|
| Fuente | Kiwa Portugal | DQS South Africa | EMKI-cert Kft. |
| Descripción | Targeted support for obtaining the CE mark under the Medical Device Regulation (MDR). This service includes auditing for ISO 13485 certification and detailed technical documentation reviews to ensure all European market access criteria are met for various medical device classes. | Specialized SANAS-accredited certification for ISO 13485, tailored for the medical device industry in South Africa. They also provide auditing for ISO 9001, ISO 14001, and ISO 45001. | Specialized certification and conformity assessment services for medical device manufacturers, ensuring compliance with EU regulations and the EN ISO 13485 standard. |
| Ideal para | CE marking support, Technical file audits, Quality assurance y Regulatory compliance | Medical device manufacturers, Healthcare suppliers, Management system auditing y SANAS accredited certification | Medical device manufacturers, EN ISO 13485 compliance, EU medical regulations y Healthcare industry quality |
| Acción | |||
| Valoración |
Si quieres empezar con la opción más equilibrada, te recomiendo:
"Medical Device CE Marking and ISO 13485 Certification de Kiwa Portugal."
Lo elegí porque Kiwa offers localized expertise in technical documentation auditing, which is critical for securing the CE marking required for sales in Portugal.