The report also found that medical device companies are taking “huge gambles” in the area of risk management.
The first critical step in being able to feel confident about your clinical evaluation reports (CERs) is to ensure you know exactly what they entail.
Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.
There has been a lot of discussion about unannounced audits, and how companies need to prepare for these. But how can you prepare for something that you don’t know about? In this discussion, four industry experts offer some suggestions.
Unannounced notified body audits are nothing new. Unfortunately, because of one really bad apple in the industry and a perception of the regulatory environment in the EU lacking teeth, the Commission has come up with an unrealistic and expensive solution for industry.
This week, the doctor provides you a brief parody on the little differences and nuances between FDA and your friendly notified bodies.