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