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
- Conformity assessment according to the Medical Devices Directive 93/42/EEC
- Conformity assessment of medical devices of animal origin according to Commission Regulation (EU) No 722/2012
- Conformity assessment of active implantable medical devices according to Directive 90/385/EEC
- We certify all medical devices (except of few “big” medical devices like, e.g. MRI)
- We have experience with various, innovative and highly complex medical devices up to combination products
Our identification number is 0482.
If you are interested in the initial certification, please refer to our checklist under Preparation for a certification.
Information about issued, suspended and canceled certificates is available upon request.