Links

This page includes all our favorite links that we've found useful to carry out our day to day safety compliance tasks.  We've also included links to service providers who provide complementary (and sometimes completing) services to our own.  We hope you'll find some of these links helpful as well.  Please feel free to contact us with suggestions for additional links.

Regulatory Organizations

Global Harmonization Task Force

US FDA

US, Dept of Commerce, Medical Device Global Regulatory Requirements

OSHA regulations and NRTL program

Health Canada

European Medical Device Directives, (europa.eu, medical device sector)

Japan Ministry of Health, Labour, and Welfare (MHW)


Medical Device Adverse Incident  Databases

While accessing device risk, or while determining the appropriateness of existing safety requirements, it can be useful to consider adverse  incidents for similar products.  The following links can be used to review reported adverse incidents.

US FDA - Manufacturer and User Facility Device Experience (MAUDE) Database

UK - MHRA Adverse Incident Reports


Standards Organizations

IECISO

IECEE Committee of Test Laboratories (CTL) - Decision Sheets

AAMI

UL

CSA

CENELECCEN

JSA

IHS - a one-stop source for buying standards, except AAMI


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

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)

Quadtech (excellent dielectric strength, earthing, and leakage current meters)

M & S Elektronik (excellent defib-proof tester)

Elgar/Sorensen (excellent variable voltage and frequency power supplies)


General Regulatory and Compliance Resources

Worldwide mains plug & socket, and voltage & frequency information at Wikipedia

Medical Device Link

Compliance Engineering 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

Safety Link, (International Product Safety News, Art Michaels)

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

Merrimack Valley Venture Forum (MVVF), 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