Medical Device Certification Consultation Hours

Whether you are a manufacturer or a consultant, we are regularly available to answer general questions and discuss the specific procedures of our certification body and notified body.

These free consultation hours take place on Fridays from 9:00 to 10:00 AM during even-numbered calendar weeks (except on public holidays and week 52). You also have the opportunity to ask questions via the MS Teams link provided.

Our goal is to inform interested parties about our procedures and criteria—of course, only to the extent permitted by our independence requirements.
This way, everyone benefits: companies gain security and confidence, while we engage with clients who are ideally prepared.

Typical topics include:

• Compliance with transition periods: When do I need to contact a notified body?

• Where to start: Management system, or clinical evaluation and technical documentation?

• When should I secure a slot with a notified body?

• When must all documentation be finalized?

• …