Interessante links in het kader van Compliance Engineering
Regulatory Organizations
Global Harmonization Task Force
European Medical Device Directives, (europa.eu, medical device sector)
- MDD Harmonized Standards and for Other Directives, (europa.eu)
- MedDev Guidance, or here
- NB-Med Guidance
- UK Medicines and Healthcare products Regulatory Agency, (MHRA, formerly MDA)
- Machinery Directive (MD) and MD Harmonized Standards
- Center for Devices and Radiological Health
- Industry Support
- Overview of FDA Regulations
- Recognized Consensus Standards
US, Dept of Commerce, Medical Device Global Regulatory Requirements
OSHA regulations and NRTL program
- Therapeutic Product Directorate
- Recognized Standards for Medical Devices
- Guidance on Transition from 2nd to 3rd ed of IEC 60601 family
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
IECEE Committee of Test Laboratories (CTL) - Decision Sheets
IHS - a one-stop source for buying standards, except AAMI
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
MET Labs certification database
Test Instrument Suppliers
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
- MD&DI Magazine
- 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
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
