Training - Training your staff on EMC design, testing, IEC 60601-1-2, 4th edition and IEC TR 60601-4-2
EMC Lab Design, Construction and Setup - Anechoic chamber, shielded rooms & general lab design, vendor negotiations, project management, lab and test equipment setup, staff training, etc.
Solutions for Manufacturers and Test Labs
We provide solutions for the challenges that manufacturers and test labs face frequently, such as;
Need help to determine the Essential Performance per IEC 60601-1?
Need help with the Risk Management requirements of IEC 60601-1-2?
Ensure the labeling requirements of IEC 60601-1-2 are complied with?
Need a test plan to comply with IEC 60601-1-2?
What is IEC TR 60601-4-2 and how does it compare with IEC 60601-1-2? Do I need to meet both? Which regulators ask for compliance to IEC TR 60601-4-2?
IEC 60601-1-2, Edition 4.1 is published and now recognized by the FDA
IEC TR 60601-4-2:2016 - EMC Performance document for Medical Electrical Equipment and Systems. Compliance to this document will likely be asked for by some regulators. Published May 2016 and is now a recognized consensus standard for the FDA. Training programs are available.