Global Reach for Medical Devices Certification
Safety and EMC:
Guidance (which standards apply, implementation of all applicable standards, etc.), full testing, check-up pre-testing (for Helsinki Committee) according to the following standards:
- IEC/EN/UL 60601-1, CSA 22.2 No. 601.1, IEC/EN 60601-2-x, IEC/EN 60601-1-x;
- Risk Management and Usability Engineering File elaboration and evaluation according to the ISO 14971 standard and IEC 60601-1-6 (IEC 62366) standards.
- Guidance and design to compliance with the requirements of the standard to support for Home Care Medical Electrical Equipment (IEC 60601-1-11);
- Experienced guidance to small companies in licensing or selling products they have developed for large organizations. Our expertise allows us to act as impartial experts in device safety during litigation.
- Monitoring and reporting on the content of selected standards, revisions and amendments for impacts to specific products and processes;
- Development of standards compliance strategies for new products (tactical) or for the entire organization (strategic);
- Guidance to compliance with the requirements of the standard to support for Home Care Medical Electrical Equipment (IEC 60601-1-11);