You manufacture medical devices. These products must be furnished with certificates in order to be allowed on the market in various countries. But this doesn’t only pertain to your products, your Quality Management System must comply with the regulations as well. ISO 13485 is the international standard for these products. As Notified Body, KEMA can combine both the product testing and the system certification in a single audit.
KEMA’s Notified Body auditor is the contact person. This auditor is also the contact for medical CE certification (AIMDD, MDD, and IVD among others).
Worldwide certification by one service provider: KEMA!
KEMA knows the medical world better than anyone. Our auditors are experts. They combine their knowledge with vast experience in the medical industry. The CE certification audits are integrated with the audits for ISO 13485. This kind of efficiency ensures that valuable audit time is saved.
KEMA is accredited to certify the following quality systems:
In addition, KEMA is also accredited for ISO 14001, 18001, and OSHA. We are totally thorough, completely independent, and extremely flexible. What’s more, we take your situation fully into consideration. KEMA understands that as a manufacturer your interests are best served when you have maximum freedom to develop new products or modify existing ones. Our method of certifying takes these things into account. And that saves you time and money.
You manufacture medical devices. These products must be furnished with certificates in order to be allowed on the market in various countries. But this doesn’t only pertain to your products, your Quality Management System must comply with the regulations as well. 
