Medical Electronics
The Medical Devices Quality Management System ISO 13485 – what are the requirements?
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ISO 13485 addresses the development, implementation and maintenance of a quality management system for medical device manufacturers and suppliers. The standard details how customer specifications and relevant regulatory requirements should be incorporated within an organisation’s quality management system. Although ISO 13485 is similar in scope and intent to ISO 9001, it also includes additional quality management system requirements specifically appropriate to an organisation involved in one or more stages of the medical device life-cycle. As a result, ISO 9001 certification is generally not an acceptable substitute for certification to the requirements of ISO 13485. Richard Poate, senior manager at TÜV SÜD Product Service, tells us more
presumption of compliance with relevant EU legislation. Health Canada also mandates that medical device manufacturers marketing their products have their quality management system certified to ISO 13485.
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buerklin.com Richard Poate I 28 December 2017/January 2018 Components in Electronics
n the European Union (EU), the requirements of EN ISO 13485 have been harmonised with the Conformity Assessment Procedures of the EU’s Medical Device Directive (93/42/EEC); the Directive for In Vitro Diagnostic Medical Devices (98/79/EC); and the Directive for Active Implantable Medical Devices (90/385/EEC). Conformity Assessment Procedures in conjunction with a certification to EN ISO 13485 by a Notified Body provides a
The ISO 13485 revision Work to revise ISO 13485 began in April 2012. As this was the revision of ISO 13485 since 2003, the ISO working group responsible faced the significant task of addressing nearly a decade of changes in technology and regulatory requirements. The revised standard ISO 13485:2016 was finally published on 1st March 2016, and has a three-year transition period for device manufacturers and other organisations certified to ISO 13485:2003. All ISO 13485:2003 certificates will expire on February 28, 2019, and the transition period is now over half completed. There are significant changes in a number of important areas:
Quality management system (Clause 4) All processes that are part of a manufacturer’s quality management system will now need to be developed using a risk-based approach. This represents a significant expansion of the risk management approach in ISO
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