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ISO 13485 resources and downloads.

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Medical Device Services

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ISO 13485
Healthcare & Medical

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.

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