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

IEC, ISO

IECEE Committee of Test Laboratories (CTL) - Decision Sheets

AAMI

UL

CSA

CENELEC, CEN

JSA

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

UL certification database

VDE certification database

TUV Rheinland certification database

TUV SUD Product Service certification database

Intertek, ETL, Semko, Warnock Hersey certification databases

CSA certification database

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

MD&DI Magazine

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