Medical device companies, listen up. There is zero excuse for not complying with medical device quality system regulations. Zero. Why? FDA has published and makes available ALL regulations required for medical device companies. Look them up by searching 21 CFR part 820. And for outside U.S., you can easily obtain ISO 13485 for a relatively […]
The newly established planning board is made up of experts representing patients, clinicians, academic researchers, the medical device industry and others, and is supported in its work by the Duke-Margolis Center for Health Policy.
By reducing administrative burden and redesigning workflows around human needs, it creates space for what matters most: connection between clinicians and patients.
Not many medical device companies are stepping up to participate in the international Medical Device Single Audit Program, which has the FDA peeved.
Medical device companies may be disconnected from the expected behaviors that a medical device company must exhibit or from the rules and regulations that govern the industry.