We reviewed 10000 live results for medical device ce marking and iso 13485 certification and narrowed them down to the 3 options that look most worth comparing first.
The strongest themes across this short list are Quality Management and Certification.
Source: Kiwa Portugal
Description
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.
Best for
CE marking support, Technical file audits, Quality assurance and Regulatory compliance
Rating
Source: DQS South Africa
Description
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.
Best for
Medical device manufacturers, Healthcare suppliers, Management system auditing and SANAS accredited certification
Rating
Source: EMKI-cert Kft.
Description
Specialized certification and conformity assessment services for medical device manufacturers, ensuring compliance with EU regulations and the EN ISO 13485 standard.
Best for
Medical device manufacturers, EN ISO 13485 compliance, EU medical regulations and Healthcare industry quality
Rating
| Compare | Medical Device CE Marking and ISO 13485 Certification | ISO 13485 Medical Device Certification | EN ISO 13485:2016 Medical Device Certification |
|---|---|---|---|
| Source | Kiwa Portugal | DQS South Africa | EMKI-cert Kft. |
| Description | 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. |
| Best for | CE marking support, Technical file audits, Quality assurance and Regulatory compliance | Medical device manufacturers, Healthcare suppliers, Management system auditing and SANAS accredited certification | Medical device manufacturers, EN ISO 13485 compliance, EU medical regulations and Healthcare industry quality |
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| Rating |
If you want the most balanced option to start with, I recommend:
"Medical Device CE Marking and ISO 13485 Certification from Kiwa Portugal."
I picked this because Kiwa offers localized expertise in technical documentation auditing, which is critical for securing the CE marking required for sales in Portugal.