What is ISO 13485?
ISO 13485:2016 establishes specific requirements for organisations that supply or manufacture medical devices.
ISO 13485 describes the requirements for a quality management system in the field of medical devices, incorporating the latest improvements in quality management, technology, and regulatory requirements.
The standard is intended for organisations involved in one or more stages of the medical device lifecycle, including design and development, production, storage and distribution, as well as installation or servicing of medical devices.
A medical device is any product used for diagnosis, prevention or treatment of a medical condition - from basic wound care products to pacemakers, life-support machines and in vitro diagnostic reagents.
Who is it for: For manufacturers, distributors and service organisations in the medical device industry.
Key Principles
Certification Benefits
Access to European and global medical device markets
Compliance with EU MDR Regulation 2017/745
Improved product quality and safety
Reduced risk of product recalls
Enhanced confidence from regulatory authorities
Systematic supplier management
Integration: ISO 13485 can be integrated with ISO 9001, while being specialised for the medical industry.
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