Certification

auditor

Certification through a neutral and independent body provides proof of compliance with industrial legal and normative requirements, thus creating trust in the marketing of products and services.

Unlike other Notified Bodies and certification companies MEDCERT is exclusively active in the field of medical devices. Experts guarantee through their dedication and reliability professional procedures at the highest level. Due to their high-level of competence we are also able to certify innovative and highly complex devices.

 

 

 

 

 


We offer the following certification services:

  • Certification according to ISO 13485
  • Certification according to the Medical Devices Directive 93/42/EEC
  • Certification of medical devices of animal origin according to Commission Regulation (EU) No 722/2012
  • Certification of active implantable medical devices according to Directive 90/385/EEC

If you are interested in the initial certification, please refer to our checklist.

Information about issued, suspended and canceled certificates is available upon request.