Since the publication of MEDDEV 2.7/1 rev4 and the Medical Devices Regulation (MDR), clinical data is under heavy scrutiny by Notified Bodies and Competent Authorities in Europe.
As the first year of its operational phase ends, the Medical Device Single Audit Program (MDSAP) is finally gaining traction among medical device manufacturers.
Twenty years after FDA first called upon manufacturers to apply human factors engineering (HFE) in medical device development, HFE has become a relatively mainstream activity. Most companies have figured out the basics of what they need to do and how to do it.
Medical devices delivered in a sterile state must be designed, manufactured, and packed to ensure they are sterile when placed on the market. However, device packaging can degrade over time or become compromised during packing, transportation, distribution, storage, or handling.
Regulatory expectations for medical device risk management are evolving toward the need for “mature” systems and processes. Recent standard revisions also emphasize patient safety - a key enabler for participating in new and emerging regulatory schemes, such as the MDR and the FDA Digital Health Software Pre-Cert Program.
The regulatory landscape is e