Common audit findings for ISO 13485 whitepaper
In this whitepaper we hear from two of LRQA’s quality experts about the common audit findings for ISO 13485 and how organisations can benefit from a medical device certification.
Oceanz case study
ISO 13485 certification to help Oceanz champion innovation and quality in life-saving, medical 3D printing technology. Read more in our case study.
ISO 13485 FAQs
LRQA's technical experts share their insight into ISO 13485 for medical device manufacturers planning to implement the international quality management system standard.
ISO 13485:2016 overview guide
Want to achieve ISO 13485:2016 certification but don’t know where to start? Download this guide for an overview of the requirements and practical guidance.
ISO 13485:2016 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.