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Discover the Benefits of ISO 13485 for your Business

White Paper: Ensuring Quality and Safety in Medical Device Manufacturing.


Register now and receive the White Paper "Discover the Benefits of ISO 13485 for your Business" free of charge.

 

Read more in our White Paper

  • What is ISO 13485?
  • Understanding ISO 13485
  • What is in it for me? Five benefits of an ISO 13485 adaptation for your business.
  • What is the legal significance of ISO 13485?
  • What you should consider when applying for ISO 13485 certification
  • Beyond compliance
  • Closing remarks

About

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 fulfil to develop, implement, and maintain management systems within the medical device industry.

Discover in this White Paper how your company can benefit from an ISO 13485 certification.

How to get your White Paper

First, you need to register. Please use the form on this page.
After registration, you will receive an email from us asking you to confirm your email address. Please note: We cannot send you the whitepaper without confirmation.
After confirming your email address, we will send you the White Paper.

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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