Four new guidelines
The guideline EDM-D-202 'Design of Electronic Medical Devices' is now available in our DfX Guidelines section.
This guideline supports the design of the electronics in active medical devices and their parts.
The guideline EDM-Q-201 'CE Certification' is now available in our Qualification Guidelines section.
This guideline aims at providing a better understanding of the EU rules related to the CE marking of products. It gives information about the responsibilities of the different economic actors when putting an electronic product into the EU market. Finally, a summary of the most important directives for electronic products is given.
The guideline EDM-Q-202 'Certification of Electronic Medical Devices' is now available in our Qualification Guidelines section.
This guideline supports the qualification and approval of electronic medical devices and the electronics in medical devices and their parts.
The guideline EDM-P-202 'Product Life Cycle Management of Electronic Medical Devices' is now available in our PLCM Guidelines section.
This guideline supports the product life cycle management aspects of electronic medical devices and the electronics in medical devices and their parts. It provides a high-level, introductory guide towards medical device management per EU-CE or US-FDA regulations.
Details of the requirements and the methodology can be found in the referenced EU and US regulations and standards.