Developing a CAPA system according to ISO 13485:2016 - By chat GPT-4

Can we not reduce the quality and regulatory burden on our most valuable resource (our people), by converging records into fewer documents?

On 6th January 2023 the European Commission published a press release concerning a new proposal- 2023/0005.

There are lots of attention grabbing changes introduced by the MDR. One of the the more obscure yet big impact changes is buried within Article 10 and concerns the mandatory need for all manufacturers, without exclusion, to have a QMS. Are you ready?

Our industry is in a critical phase of change, and increased regulatory burden on manufacturers, practically means additional costs associated with achieving regulatory compliance.