ISO 13485:2016

Medical devices — Quality management systems — Requirements for regulatory purposes

ISO 13485 Consultants

Our ISO 13485 consultants are helping manufacturers and those in the supply chain to implement the internationally recognised standard for quality throughout the lifecycle of medical devices.

At its core, ISO 13485 is a quality management standard, however the latest revision (2016) departs from the Annex SL and ISO 9001 structure you might recognise.
Therefore ISO 13485 is a stand-alone standard that provides requirements for a quality management system specifically to meet the needs of medical devices.

What is a Medical Device?

Medical Devices include instruments, machines, implants or vitro reagents that are used for diagnosis, prevention and treatment of medical conditions.

ISO 13485 Certification

The Accredited certification scheme organisations can become ISO 13485 Certified via a two stage process.
Stage One is generally considered a documentation check which Stage 2 involves sampling and evidence based audits. Our ISO 13485 consultants can guide you through the whole process.

ISO 13485 in the Supply Chain

The safety and quality of medical devices in the supply chain is of utmost importance to every stakeholder involved.
Independent Accredited ISO 13485 Certification provides assurance for your customer that a quality management system has been implemented and impartially audited.

ISO 13485 & Regulators

Regulators in many countries recognise the ISO 13485 standard, and while achieving ISO 13485 certification does not automatically mean compliance with every legal requirement, such as the Medical Device Directives; if implemented properly it gives a firm foundation and framework for managing compliance.

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ISO 13485 Consultants – How we can help!

Our ISO 13485 Consultants are experienced in implementing quality management systems related to medical devices.
We will guide you through the process by providing consultancy, access to example documentation and online tools.
We can help raise awareness of the requirements throughout your organisation and support you during your ISO 13485 Certification audit.

Contact Us!