Medical 4th Edition EMC / Transitioning to IEC 60601-1, Edition 3.1 /5 Steps to Medical Device Commercialization for the United States
Download our easy guides.
Intertek is offering readers 3 easy guides to help with their compliance planning:
- Medical 4th Edition EMC
The latest version of IEC 60601-1-2 4th Edition increases the focus on the EMC profile of the medical equipment, this quick fact sheet provides and overview of what you need to know.
- Transitioning to IEC 60601-1, Edition 3.1
As the evolving 60601-1 standard increasingly puts greater emphasis on risk management and essential performance, this white paper provides a summary of the requirements and recommendations for global implementation.
- 5 Steps to Medical Device Commercialization for the United States
Bringing medical devices to market in the United States is a complex process that requires an in-depth understanding of all that is involved in classifying a device, preparing a pre-market submission and submitting to the Food and Drug Administration (FDA). This white paper takes you step by step through the process.
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