ISO 13485:2016 - Gap Analysis
Based upon the findings, your assessor will advise whether your organization is ready for assessment or indicate areas requiring further attention.
Case study: ISO 13485 and ISO 9001 certification
Find out why Oceanz, a professional 3D printing company, decided to obtain certification against ISO 13485 in addition to their existing ISO 9001 certification.
Medical Device Services
Download and learn why the world’s leading medical companies choose LR.
ISO 13485:2016 – Wondering where to start?
This guide is intended as a starting point for medical device manufacturers currently certified to an existing version of ISO 13485.
Interview Part 2: The New ISO 13485:2016
Overview of ISO 13485:2016 (Medical Devices – Quality Management Systems - Requirements for Regulatory Purposes)
Interview: Overview of ISO 13485:2016 and how it impacts manufacturers
This interview is the first of a two-part series where Susan Mecca, LR Technical Manager, Medical Devices, shares her thoughts on the new ISO 13485:2016.