ISO 13485 Frequently Asked Questions
LR’s technical experts share their insight into ISO 13485 for medical device manufacturers planning to implement the international quality management system standard.
Medical Device Single Audit Program
Download the MDSAP factsheet to learn about the benefits of the program and how your organisation can meet compliance.
ISO 13485:2016 & MDSAP Gap Analysis Factsheet
Download our factsheet to learn how a gap analysis can help you focus on high risk or weak areas of your medical device QMS ahead of your formal assessment visit.