An independent consulting firm providing expertise to enable products to comply with global ELECTROMAGNETIC COMPATIBILITY (EMC) requirements. Serving all industries with special emphasis on medical devices and ITE products.
Darryl Ray EMC Consulting, LLC
- EMC Design - Review of PCB schematics & layouts, enclosure design,mechanical construction, internal and external cabling design, etc.
- Mitigations - Problem analysis, on site troubleshooting with a portable spectrum analyzer, prototype fixes, support design engineering on redesigns, EMC component vendor liaison, etc.
- EMC Testing & Documentation - Perform testing at customer facility, testing oversight, generate test plans, review and generate test reports
- Risk Analysis - Work with the design and test teams to address Risk Management as required by IEC 60601-1-2 4th edition
- EMC Standards - Guidance and interpretation of numerous EMC standards and regulations. (e.g. demystifying the ESD test requirements on connectors per IEC 61000-4-2)
- EMC Regulatory Engagement & Support - Provide support for FDA, FCC, Health Canada, KFDA, ANVISA, CE Mark and other agency approvals. Provide guidance to FDA questions on 510(k) submittals
- Medical Device EMC Labeling - Review accompanying documents for compliance to IEC/EN 60601-1-2 clause 5 requirements
- Training - Training your staff on EMC design, testing, IEC 60601-1-2, 4th edition and IEC TR 60601-4-2, 1st edition
- EMC Lab Design, Construction and Setup - Anechoic chamber, shielded rooms & general lab design, vendor negotiations, project management, lab and test equipment setup, etc.
Frequent challenges for manufacturers and test labs
- Need help to determine the Essential Performance per IEC 60601-1?
- Need help with the Risk Management requirements of IEC 60601-1-2?
- Need help with the labelling requirements of IEC 60601-1-2?
- Need a test plan to comply with IEC 60601-1-2?
- What is the new IEC TR 60601-4-2 and how does it compare with IEC 60601-1-2? Both I need to meet both?
We can help!
- IEC 60601-1-2, Edition 4 will become mandatory in the US (for new submittals), the EU and Canada on January 1, 2019 (for all devices).
- 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 regulators. Published May 2016 on is now a recognized consensus standard for the FDA. Training programs are available.
Darryl Ray EMC Consulting, LLC firstname.lastname@example.org 925-487-0072