Services for Faster Market Access

Achieving global market access for medical devices quickly becomes a costly and time-consuming endeavor. The alliance between CSA Group as one of the world's leading medical device testing organizations and BSI, one of the leading Notified Bodies in Europe, brings together an unrivalled mix of expertise, enabling you to create and bring your medical devices to patients and healthcare professionals all over the world — FASTER and more PREDICTABLY.

We can help you access global markets with services including:


Testing — IEC 60601 (incl. 2nd and 3rd edition)

Do you require testing of your electro-medical devices according to IEC 60601? We can test your medical electrical equipment to ensure it complies with this crucial safety standard and its edition updates, so you can save costs and time through simplified acceptance and an expedited process.


Technical File Review — CE Marking

If you want to place your electro-medical devices on the European market, they have to comply with the Medical Devices Directive. Compliance typically involves a review of the technical files. As a Notified Body, we will work with you, helping you understand and comply with the essential requirements, enabling you to confidently and legally affix CE marking to your products.


QMS Assessment — ISO 13485

To meet the comprehensive requirements for a Quality Management System (QMS), ISO 13485 is an effective solution to ensure consistent design, development, production, installation, delivery and disposal of medical devices that are safe for their intended purpose. We can help you adopting ISO 13485 as a practical foundation to address regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.


In case you are looking for additional services to get your products to global markets, we can also provide you with a wide range of individual medical device testing and certification service offerings. To learn more, please visit CSA Group and BSI individually.