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Disclaimer: Links to organizations found at this site are provided solely as a service to our visitors. These links do not constitute an endorsement of these organizations or their programs by Eisner Safety Consultants, and none should be inferred. Eisner Safety Consultants is not responsible for the content of the Web pages found through these links

This page includes some of our favorite links that we find are necessary to do our every day regulatory & compliance work.  We hope you find these resources helpful.  Please contact us with any suggestions for additional links or if you find any broken links.

Certification Safety Agencies

These agencies provide a variety of services such as safety testing & certification services, emc testing, 510(k) third party review, CB scheme certification, EU MDD/AIMDD/IVD Notified Body Certification, and Quality Management Certification

TUV SUD Canada
UL
TUV Rheinland
CSA International
Intertek, ETL/SEMKO

TUV SUD America
VDE Testing & Certification
Curtis Straus/Bureau Veritas
Nemko

Third Party Test Houses

Independent third party test houses that we have worked with to help our clients thru the Safety testing/certification &/or EMC testing process

Global EMC, Inc.
Medical Equipment Compliance Associates (MECA)
OBrien Compliance Management
G&M Compliance
NorthWest EMC
CKC Laboratories
Elliott Laboratories (Now called NTS)

Standards Organizations

IEC
ISO
CENELEC
CEN
AAMI
ANSI
ASTM
National Fire Protection Association (NFPA)
FCC
FCC Search Tools

BSI
UL
CSA
Japanese Standards Association (JSA)
Standards Administration of China (SAC)
Japan Quality Assurance Organization (JQA)
VDE
National Institute of Standards & Technology (NIST)
NIST – Standards & Technical Regulations – Great Resource!

Standards Sales Organizations

TechStreet (Thomson Reuters)
Document Center, Inc.
IHS
AAMI Store
IEC Webstore
ISO Webstore
Comm 2000 (UL standards)

 Regulatory Agencies

Global Harmonization Task Force
FDA (US)

OSHA Nationally Recognized Testing Labs (NRTL) Program
US Dept. of Commerce, Medical Device Global Regulatory Information
Health Canada

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

Australian Therapeutic Goods Administration (TGA)
Japan Ministry of Health, Labour, and Welfare (MHW)

Certification Databases

Resource where you can find certificates for products & components from various certification organizations

UL
CSA
VDE
IECEE CB
TUV SUD (America – Previously TUV Product Service)
TUV Rheinland
Intertek, ETL, Semko, etc.

Test Equipment Suppliers

QuadTech
Fluke Biomedical
Associated Research
Vitrek

Language Translation Services

Foreign Exchange Translations
Biomedical Translations

Regulatory Resources
Adverse Incident Reporting Databases – Medical Devices

The following links can be useful for comparing your product against other reported product incidents.  Also, can be a useful tool for determining appropriateness of existing safety requirements or assessing device risks.

Manufacturer and User Facility Device Experience (MAUDE) – US FDA
Adverse Incident Reports – UK MHRA

Biocompatibility, Toxicity, Sterilization Testing

NAMSA
Nelson Labs
Toxikon

Compliance Resources

Medical Device Link (DeviceLink – Cannon Communications)

Safety Link Website – useful resource
Worldwide mains plus & sockets (voltage & frequency info) – Wikipedia
IEC Just Published