Busca ao vivo
O TopFind está buscando as correspondências mais recentes para a sua pesquisa.
Analisamos 10000 resultados ao vivo para medical device ce marking and iso 13485 certification e reduzimos para 3 opções que parecem valer mais a comparação primeiro.
Os temas mais fortes nesta lista curta são Quality Management e Certification.
Fonte: Kiwa Portugal
Descrição
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.
Melhor para
CE marking support, Technical file audits, Quality assurance e Regulatory compliance
Avaliação
Fonte: DQS South Africa
Descrição
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.
Melhor para
Medical device manufacturers, Healthcare suppliers, Management system auditing e SANAS accredited certification
Avaliação
Fonte: EMKI-cert Kft.
Descrição
Specialized certification and conformity assessment services for medical device manufacturers, ensuring compliance with EU regulations and the EN ISO 13485 standard.
Melhor para
Medical device manufacturers, EN ISO 13485 compliance, EU medical regulations e Healthcare industry quality
Avaliação
| Comparar | Medical Device CE Marking and ISO 13485 Certification | ISO 13485 Medical Device Certification | EN ISO 13485:2016 Medical Device Certification |
|---|---|---|---|
| Fonte | Kiwa Portugal | DQS South Africa | EMKI-cert Kft. |
| Descrição | 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. |
| Melhor para | CE marking support, Technical file audits, Quality assurance e Regulatory compliance | Medical device manufacturers, Healthcare suppliers, Management system auditing e SANAS accredited certification | Medical device manufacturers, EN ISO 13485 compliance, EU medical regulations e Healthcare industry quality |
| Ação | |||
| Avaliação |
Se você quer começar pela opção mais equilibrada, eu recomendo:
"Medical Device CE Marking and ISO 13485 Certification de Kiwa Portugal."
Eu escolhi isso porque Kiwa offers localized expertise in technical documentation auditing, which is critical for securing the CE marking required for sales in Portugal.