ISO 13485:2016 – Medical devices and related services – Launch of the certification process

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On April 23, Vulkam started the process with the aim of obtaining ISO 13485:2016 certification in 2022.

ISO 13485:2016 standard

Vulkam, with the new innovative zirconium-based Vulkalloy® Zr-Med material for the medical industry, addresses the Bio medical industry, which requires compliance with the requirements of the new regulation 2017/745 and the ISO 13485:2016 standard.

The standard sets out the requirements for a quality management system (QMS) where an organisation needs to demonstrate its ability to consistently deliver medical devices and associated services that meet customer and applicable regulatory requirements.

Implementation at Vulkam

We are accompanied by Jennifer NEEL, consultant, auditor and trainer in the pharmaceutical, cosmetic and medical device fields, within the Qualinove firm, specialised in Quality Safety Environment Management.

The implementation follows a 5-phase plan: Audit – Report in the form of a gap analysis – Action plan – Construction of the QMS – Blank audit

ISO 13485 médical

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