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  • Topic: Implications of the new Medical Device Regulation (MDR) from a
    product testing and certification perspective
  • Duration: 45min
  • Language: English
  • Content: This webinar will introduce you to the changes of the new MDR and how they will impact your product research, design and development through to placing your product on the European market.

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Medical device manufacturers face new challenges when trying to access the European market. Reason for this is the recent publication of the new Medical Device Regulation (MDR). The MDR will have a significant impact on clinical, preclinical and biocompatibility performance as well as other technical requirements.

The new regulation will bring about significant changes for your business and it’s important to understand the implications early and start planning your transition immediately.

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About CSA Group and BSI:

The alliance between CSA Group as one of the world’s leading medical device testing and certification organizations and BSI, one of the leading Notified Bodies in Europe, brings together an unrivaled mix of expertise, enabling you to create and bring your medical devices to patients and healthcare professionals all over the world — FAST and PREDICTABLY.

We understand that speed and certainty about project deadlines is paramount when accessing global markets. Therefore, our one-stop service guides electro-medical device manufacturers through the key stages of market access:

  • Product Testing according to IEC 60601
  • CE-Marking incl. Technical File Review
  • Quality Management System Assessment according to ISO 13485

Contact us today to learn more or get started!


Event Details

January 1 - December 31, 2017

Canada, United States, Singapore, Korea, Japan, Hong Kong, Turkey, Switzerland, Italy, India, Taiwan, Netherlands, Germany, China, United Kingdom