ISO 13485 is the globally recognised quality management system (QMS) standard in the medical device industry.
The standard outlines the requirements that medical device manufacturers and suppliers must fulfill to develop, implement, and maintain management systems within the medical device industry.
Discover in this White Paper how your company can benefit with an ISO 13485 certification.
Author
Szymon Kurdyn
Szymon Kurdyn is Head of the Notified Body (non-active medical devices) and Product Manager for ISO 13485 (DAkkS accreditation). In this position, he keeps an eye on the regulatory and normative framework of certification activities, is in close contact with authorities, our experts and our customers and informs about changes and other relevant topics.
Author
Claire Dyson
Claire Dyson has a doctorate in rational drug design and over 10 years of experience in medical devices that interact with or deliver medicines or biological responses. Most of her career has been spent in industry, mainly in Switzerland. She moved into certification bodies in 2018 and has been involved in several transformative change projects, including new accreditations and designations
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