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ISO 13485 – Medical Devices


What is ISO 13485?

ISO 13485:2016 is an international recognized standard that identifies the requirements for a Quality Management System for the medical devices industry.     It was developed to be used by organizations throughout the entire life cycle of a medical device, from design to production and post production including end of life decommissioning and disposal.  It was developed to be used by organizations throughout the entire life cycle of a medical device, from design to production and post production including end of life decommissioning and disposal.

As ISO 13485 is a stand alone standard, it is similar in scope and intent to ISO 9001:2008 as it does not follow the high-level structure of the ISO 9001:2015 version.   In addition, documentation and safety requirements are more emphasised in ISO 13485:2016, whereas ISO 9001:2015 places more emphasis on customer satisfaction and continual improvement.

The Benefits of ISO 13485:

→ Demonstrates a commitment to quality, customers, and a willingness to work towards improving efficiency.

→ Demonstrates the existence of an effective quality management system that satisfies the rigours of an independent, external audit and addresses additional safety, regulatory and quality concerns specific to the medical device industry.

→ Enhances company image & credibility in the eyes of customers and shareholders alike.

→ Greater emphasis placed on risks associated with the safety & performance of medical devices along with compliance

→ Gives a competitive advantage in marketing efforts

Who is it relevant to?

ISO 13485 is suitable for any organization involved in the design, production, storage, distribution, installation and servicing of medical devices. By implementing a quality management system based on requirements outlined in ISO 13485, it will give customers confidence in  an organizations ability to bring safe and effective medical devices to market that consistently meet the requirements of customers and applicable regulations.

Why choose us?

Over the years, ISO Atlantic has helped several companies with their implementation of ISO 13485.   We’d be happy to assist your company in exploiting its strengths and help you reach your market potential.     

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