ISO 13485:2016 gap analysis factsheet
This gap analysis focuses on how your medical management system has addressed or plans to address the ISO 13485 requirements.
Oceanz: Making life-saving, medical 3D printing a reality.
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 overview FAQs
LR’s medical device technical experts answer frequently asked questions to support manufacturers with the transition and address the changes that the ISO 13485:2016 revision has introduced.
Looking for answers on how to implement ISO 13485?
Experts from Lloyd's Register answer some of the most frequent questions about implementing ISO 13485 and maintaining an effective management system.
ISO 13485:2016 factsheet
More and more medical device manufacturers require suppliers and service providers to be certified to ISO 13485 as a pre-requisite for doing business. Learn more about how to achieve compliance.
Penlon: Quality at its core.
Find out about the steps that Penlon took before pursuing ISO 13485:2016 certification, key learnings from their transition process and tips for organisations looking to change Certification Body.