People in the medical device (MD) field should know by now that today’s 93/42/EEC medical device directive will be obsolete. It means that start-up planning to put devices will face challenges brought by the Medical Device Reporting. That is why product development plans need to include a detailed analysis of the life cycle phases of medical devices against the new Medical Device Reporting requirements.

It is imperative to realize what the term lifecycle means: all phases in the MD lifespan, from its conception to disposal and final decommissioning. That is why people need to think about the certification process during … Read More..