The main media story locally in the UK in January 2024 has to be the Post Office scandal relating to the faulty Horizon IT system and the unjustified prosecution of Post Office Ltd Sub-Postmasters.

The only point at which manufacturers should rest from their MDR journey is after they have obtained an MDR certificate.

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?

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