The biggest changes in medical device regulation since the implementation of CE marking!  We can help you get informed and stay on top of your new requirement needs!

• Clinical Evaluation
• Post Market Clinical Follow up
• Post Market Surveillance

We can help…

Post Market Clinical Followup (PMCF) is undertaken in a variety of circumstances:

1. At the direction of your Notified Body as a requirement for ongoing CE Mark certificates
2. At the direction of a regulatory authority
3. As an outcome of either clinical evaluation, post market surveillance or vigilance
4. To gain knowledge from first in human uses
5. Assess feasibility and acceptance
6. Collect long term use data    (see more details...)