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medical device ce marking and iso 13485 certification에 대한 실시간 결과 10000개를 검토하고, 먼저 비교할 가치가 높은 3개의 옵션로 좁혔습니다.
이 후보 목록에서 가장 강한 주제는 Quality Management 및 Certification입니다.
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medical device ce marking and iso 13485 certification에 대한 실시간 결과 10000개를 검토하고, 먼저 비교할 가치가 높은 3개의 옵션로 좁혔습니다.
이 후보 목록에서 가장 강한 주제는 Quality Management 및 Certification입니다.
출처: Kiwa Portugal
설명
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.
추천 대상
CE marking support, Technical file audits, Quality assurance 및 Regulatory compliance
평점
출처: DQS South Africa
설명
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.
추천 대상
Medical device manufacturers, Healthcare suppliers, Management system auditing 및 SANAS accredited certification
평점
출처: EMKI-cert Kft.
설명
Specialized certification and conformity assessment services for medical device manufacturers, ensuring compliance with EU regulations and the EN ISO 13485 standard.
추천 대상
Medical device manufacturers, EN ISO 13485 compliance, EU medical regulations 및 Healthcare industry quality
평점
| 비교 | Medical Device CE Marking and ISO 13485 Certification | ISO 13485 Medical Device Certification | EN ISO 13485:2016 Medical Device Certification |
|---|---|---|---|
| 출처 | Kiwa Portugal | DQS South Africa | EMKI-cert Kft. |
| 설명 | 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. |
| 추천 대상 | CE marking support, Technical file audits, Quality assurance 및 Regulatory compliance | Medical device manufacturers, Healthcare suppliers, Management system auditing 및 SANAS accredited certification | Medical device manufacturers, EN ISO 13485 compliance, EU medical regulations 및 Healthcare industry quality |
| 작업 | |||
| 평점 |
가장 균형 잡힌 옵션부터 보고 싶다면 다음을 추천합니다:
"Medical Device CE Marking and ISO 13485 Certification 출처 Kiwa Portugal."
이 항목을 선택한 이유는 Kiwa offers localized expertise in technical documentation auditing, which is critical for securing the CE marking required for sales in Portugal.