Eisner Safety Consultants

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

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 Advantage
Medical Equipment Compliance Associates (MECA)
OBrien Compliance Management
G&M Compliance
NorthWest EMC
CKC Laboratories
Elliott Laboratories

Standards Organizations

Standards Sales Organizations

TechStreet
IHS Global Engineering
AMMI

Regulatory Agencies

Global Harmonization Task Force
FDA (US)

• Device Advice
• Medical Device Guidance Documents
• Recognized Consensus Standards
• Code of Federal Regulations – CFR Title 21

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

• Therapeutic Products Directorate (TPD)

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

• EU Harmonized Standards (MDD, AIMDD, IVDD, etc.)
• UK Medicines and Healthcare products Regulatory Agency (MHRA, formerly MDA)

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)

• MD&DI Magazine – Multiple articles by Leo Eisner
• Compliance Engineering Magazine - Multiple articles by Leo Eisner
• Medical Electronics Manufacturing (MEM) – Article by Leo Eisner
• Medical Product Manufacturing News (MPNN)
• MX Magazine
• IVD Technology Magazine
• European Medical Device Manufacturer
• Medical Device Technology
  • Article on USB isolation technique, single component solution, for medical devices
• Med-Tech Precision
• Pharmaceutical & Medical Packaging News
• SourceBook
• China Medical Device Manufacturer (CMDM)

Conformity Magazine
Safety Link Website – useful resource
Worldwide mains plus & sockets (voltage & frequency info) – Wikipedia
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