Laura Taylor
Laura Taylor is a Consultant at Real Regulatory, with a history of working in the medical device industry. She is skilled in working in Internal Audit, Quality Management, ISO 13485, MDSAP, Clinical Evaluation Reports, and NC/CAPA.
JournalSuccessful transition of your ISO 13485 QMS from MDD/IVDD to MDR/IVDR
The new requirements in the MDR/IVDR will affect the QMS of medical device manufacturers, however, use of the ISO 13485 standard is a useful starting point in meeting many of these requirements. The use of a gap analysis, project implementation plan, and ISO 13485 provide an approach that will allow manufacturers to successfully transition from MDD/IVDD to MDR/IVDR.