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ISO 13485 Certification Resources & Downloads.

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ISO 13485 overview guide

ISO 13485 certification is one of the best ways to demonstrate compliance with the various laws and regulations active in the medical devices industry. This overview guide is intended as a starting point for organizations considering to get their management system certified.

ISO 13485
Healthcare & Medical

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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