Support Links
Support Links were found to be accurate in Jan 2022. If you find a broken Link or have suggestions for new Link, let us know.
We've listed these Service Providers and Support Groups for your convenience. Their inclusion is not an endorsement. Our expectation is you'll assess their ability to deliver needed services and information.
Standards Organizations
IECEE Committee of Test Laboratories (CTL) - Decision Sheets
IHS - a one-stop source for buying standards, except AAMI
Regulatory and Quality Management System Consultants
Services include: 510(k), PMA, Type Exam, and setting up a Quality Systems.
AlvaMed, Mark Cox, Waltham, MA
Peter Olive, Medical Device Consulting (MDC) Services, tel 781-864-2293, email prox555@yahoo.com
cGMP Services, Bill Hillenberg, Westford, MA
MedApprove, Jim & Penny Greco, Kittery, ME
Eisner Safety Consultants, Leo Eisner, Portland, OR
ZenDoc, Robert Fenton, Dublin, Ireland; Cloud-based software for your quality management system
Safety Consultants
The following are consultants with whom we have worked together. All are expert, responsive medical device compliance specialists. We've included the name of the principal, and the office location.
We recommend Device Conformity and Testing, Gregg Edwards, Devens, MA
Medical Equipment Compliance Associates, LLC, Brian Biersach, Franklin, WI
Eisner Safety Consultants, Leo Eisner, Portland, OR
MedApprove, Jim & Penny Greco, Kittery, ME
ActiveAlliance, Dale Hallerberg, Chicago, IL
Supply Chain Management and Operations
We recommend:
Krull Engerprise Services, Wolfgang Krull, wkrull@kessco.net
Certification Databases
Places to find certified components and accessories
IECEE CB certification database
TUV Rheinland certification database
TUV SUD Product Service certification database
Intertek, ETL, Semko, Warnock Hersey certification databases
Eurofinis/MET Labs certification database
British Standads Institute certification database
Test Instrument Suppliers
Newark InOne (general supplier of Tektronix, Fluke, Agilent, Superior, Sola/Hevi-Duty, Weller equipment, and many others)
Chroma (formerly Quadtech, excellent dielectric strength, earthing, and leakage current meters)
M & S Elektronik (excellent defib-proof tester)
Ametek (formerly Elgar/Sorensen, excellent variable voltage and frequency power supplies)
General Regulatory and Compliance Resources
Worldwide mains plug & socket, and voltage & frequency information at Wikipedia
ITE Power Supplies and Medical Equipment, by Frank O'Brien, president of OBCM, Feb 2000
A New U.S. National Standard for Medical Devices, co-authored by Frank O'Brien, president of OBCM, Sep 2006
In Compliance Magazine (formerly Conformity)
What's New in EMC Standards for Medical Devices, co-authored by Frank O'Brien, president of OBCM, Aug 2007
BioSpace, (Information about life science industry)
Support Groups
MedDevGroup Meetings, Boston Area
Northeast Product Safety Society, Boston Area
Massachusetts Medical Device Industry Council (MassMEDIC), Boston area
Massachusetts Medical Device Development Center (M2D2), UMass Lowell, UMass Worcester, Boston area
Advanced Medical Technology Association (AdvaMed), (formerly HIMA), Washington DC area
Regulatory Affairs Professional Society, (RAPS), Washington DC area