Post-market requirements outlined in the regulation carry significant process challenges and procedure updates. Start simple and try not to overcomplicate your processes.
The Avalus pericardial surgical valve is intended for patients with aortic valve disease.
When entering this emerging market, the benefits may outweigh any risks.
An awareness of the European regulations and the definitions is essential when pursuing a CE Mark for a combination product.
The long awaited unannounced audits for manufacturers of CE marked medical devices were started last year by almost all Notified Bodies. So how can manufacturers prepare for the changes?