Welcome to Pacific EMC

Formerly known as Darryl Ray EMC Consulting, LLC
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Darryl P. Ray Founder & Principal Consultant

​Services Offered
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NEW!

Introduction to Medical EMC training by Darryl Ray
May 9 (1PM-5PM) - May 10 (all day)
Early Bird registration ends March 24, 2024 (save $100)
emc-seminar

Medical Product Safety (IEC 60601) training by Frank O'brien
May 6,7,8 (all day) - May 9 (8AM - 12PM) 
Early Bird registration ends March 24, 2024 (save over $250)
safety-seminar
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​Both training class will be held in Boxborough, Mass.
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  • EMC Design - Review of PCB schematics & layouts, enclosure design, mechanical construction, power supply selection and internal placement, 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 using customer supplied test equipment, 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, CE Mark and other agency approvals. Provide guidance to FDA questions on 510(k) and PMA submissions
 
  • 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
 
  • 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?
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  •  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?

Current Topics

  
  • IEC 60601-1-2, Edition 4.1 (2020) Recognized by the FDA replacing Edition 4.0
 
  • IEC TR 60601-4-2, Edition 1.0 (2016) - (Edition 1.1 version coming soon) EMC Performance document (not Essential Performance) for Medical Electrical Equipment and Systems. Compliance to this document will likely be asked for by some regulators.  It is a recognized consensus standard for the FDA. Training programs are available

Pacific EMC                                  
[email protected]                                 
​925-487-0072