Effectively Reviewing GMP Documents: A 10-Step Guide
Good manufacturing practice (GMP) documents are the backbone of pharmaceutical quality systems. It serves as controlled records that ensure consistency, traceability, and compliance with regulatory standards. We have prepared a comprehensive guide on how to review GMP...
5 EU MDR Medical Device Software (MDSW) Requirements
EU MDR defines medical device software (MDSW) as a software with medical purpose, whether standalone or embedded in a device. MDSW is regulated as an active medical device. Its classification is primarily determined by Rule 11 of Annex VII. Most diagnostic or...
Roles of Person Responsible for Regulatory Compliance (PRRC)
Person Responsible for Regulatory Compliance (PRRC) is a mandatory requirement under Article 15 of the EU Medical Device Regulation (MDR). It requires manufacturers and authorized representatives to appoint a qualified individual with expertise in regulatory affairs...