The Medical Device Labelling Process Needs to Start Early in Design Controls
Mislabeled and misbranded medical devices are one of the top three causes for recalls in the United States. Companies can...
Over an eight-year span, the gap between the number of OEM transactions versus those in the supplier space was its...
The initiative is designed to mitigate risk associated with readmissions in value-based healthcare reimbursement models....
The rule amends that inspections will be risk-based, not biennial....
RMP manufactures UHMWPE used in long-term human implantable applications, especially those in the orthopaedic industry....
UDI requirements have led to layers of regulatory decoding, data collection and dissemination, additional costs and moments of confusion, annoyance...