ISO 13485 medical devices explained 

ISO 13485 medical devices explained 

Posted by:caragh.oneill
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ISO 13485 is the international stand for organisations involved in the medical device sector. It is suitable for organisations in the design, production, installation, and servicing of medical devices and related services.

ISO 13485:2016, the Medical Device Quality Management System standard, has been harmonized to the European Medical Devices Directives: MDD, AIMDD, and IVDD. EN ISO 13485:2016 now replaces the previous version of the standard, EN ISO 13485:2012. ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance with the laws and regulations of the medical device industry.

ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives and Regulations. Standard harmonization allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation.

The benefits of ISO 13485 cannot be overstated. Quadra has worked with a wide range of medical device companies in helping them to achieve certification to the standards.

ISO 13485 is the internally recognised ‘gold standard’ for quality in the medical device industry. Certification to this standard provides a structure for ensuring that the medical device complies with the medical directive and CE markings.

The ISO 13485 contains many similar requirements to ISO9001 with the standards complimenting each other in many areas.

Certification to ISO13485 can prove to be a useful tool in accessing new markets.

Our experienced ISO 13485 consultants can support you with implementing an efficient quality management system in compliance with and able to get certificated to ISO 13485. We provide ISO 13485 consulting solutions suitable for organisations across various industries that are tailored to the needs of each individual client.

If you wish to discuss the potential benefits of implementing ISO standards please do not hesitate to contact us at 028 9042 3222 or 01 8321493 or [email protected]. More information can be found at

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