Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
The adoption of the 3rd Edition of IEC 60601-1 has been slow since its release in December 2005. Each country’s testing agencies and regulatory bodies are transitioning to the 3rd Edition at a different pace, making it difficult to develop a consolidated test plan.
However, the time is critical to most medical device manufacturers:
But what does your company need to do if it still not registered? What steps need to be taken now to ensure that your device meets the standards under Third Edition?