This page includes some of our favorite links we find useful in our everyday regulatory & compliance work. Please contact us with any suggestions for additional links or if you find any broken links. We hope you find these resources helpful.
Link Subjects (Jumps to Links Page):
Certification Safety Agencies
Third Party Test Houses
Standards Organizations
Standards Sales Organizations
Regulatory Agencies
Certification Databases
Test Equipment Suppliers
Regulatory Resources
Adverse Incident Reporting Databases – Medical Devices
Biocompatibility, Toxicity, Sterilization Testing
Compliance Resources
Certification Safety Agencies
These agencies provide a variety of services such as safety testing & certification services, EMC testing, CB scheme certification, EU MDD/AIMDD/IVD/ Notified Bodies, MDR/IVDR Designated Bodies, and Quality Management Certification. Most links point to the Medical Device area of the organization.
Bureau Veritas/Curtis Straus
CSA Group
Intertek (previously ETL & SEMKO)
Nemko
TUV SUD America
TUV SUD Canada
UL
eurofins MET Labs
TUV Rheinland
BSI (US)
VDE Testing & 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
Medical Equipment Compliance Associates (MECA)
G&M Compliance
Element EMC Testing (Previously NorthWest NorthWest EMC)
CKC Laboratories
OBrien Compliance Management (Sold off test house – training only – We also offer training)
NTS (Previously called Elliot Labs)
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
Document Center, Inc.
IHS
AAMI Store
IEC Webstore
ISO Webstore
ANSI Webstore
BSI Webstore
ASTM Webstore
NFPA Catalog
Comm 2000 (UL standards)
Regulatory Agencies
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
Health Canada
Therapeutic Products Directorate (TPD)
European Commission, Medical Device Regulatory Framework
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)
International Medical Device Forum (IMDRF)
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
Chroma Systems Solutions (Formerly QuadTech)
Fluke Biomedical
Associated Research
Vitrek
Regulatory Resources
Country / Region Regulatory Resources
Medical Device Directive (MDD) Consolidated Version (includes revisions up to September 2007)
EC Interpretative Document on the Implementation on the MDD & AIMDD Amendment 2007/47/EC
Harmonized Standards
List of Harmonized Standards for the MDD
Team Notified Body (Team NB) Report on EU Languages for MD, AIMD, & IVD Directives July 2007 (Outdated but a reference pt)
Medical Device Directive Guidance Documents (MEDDEVs), Consensus Statments, & Informative Documents
Notified Body Recommendations (MDD)
Active Implantable Medical Devices Directive (AIMDD) Consolidated Version (includes revisions up to September 2007)
EU Medical Device Sector Information Web Page (includes links to new regulations, tools & db’s, news, events, contracts & grants, public consultations, publications, etc.)
In vitro Diagnostic Directive (IVDD) (includes revisions up to September 2003)
Restriction of the use of Certain Hazardous Substances in Electrical and Electronic Equipment Directive (RoHS) (Also known as RoHS2)
Waste Electrical and Electronic Equipment Directive (WEEE) Consolidated VersionAdverse 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 MHRABiocompatibility, Toxicity, Sterilization Testing
NAMSA
Nelson Labs
Toxikon
Compliance Resources
MD&DI Magazine – Multiple articles by Leo Eisner
Compliance Engineering Magazine – Multiple articles by Leo Eisner
Medical Electronics Manufacturing (MEM) – Article by Leo Eisner
China Medical Device Manufacturer (CMDM)
Worldwide mains plus & sockets (voltage & frequency info) – Wikipedia
IEC Just Published(sign up for IEC news letter at bottom of page)
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