Medical Device Services
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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.
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.
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.
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.