Laura Taylor
Laura Taylor is Regulatory and Quality Consultant at Advena Ltd.
JournalFrom design to diversity: Embedding women’s health into medical device innovation and regulation
This article analyses how to integrate women’s health considerations to ensure inclusivity throughout the medical device development lifecycle.
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.