Links to Useful & Informative Web Sites & Documents...

Useful, FREE Documents & Software:

Medical Terms Dictionary (Excellent!!)

Convert to and from virtually all units of measure

IEC 60601-1 Ed. 3: 2006 Compliance Guide (Sample)

IEC 60601-1 Ed. 3– Risk Management Requirements List

IEC 60601-1-2 Ed. 2: 2001 vs. Ed. 1:1993 Comparison (Sample)

ISO 14971 Risk Management Compliance Evaluation Package

IEC 60601-1-4 Programmable Systems Global Compliance Report From

IEC 60601-2-38 Hospital Bed Global Test Report

IEC 60601-2-46 Operating Table Global Test Report

IEC 60601-1 Ed. 2: 1998 Global Test Report

IEC 60601-1-6 Ed 2 Usability Collateral Standard Compliance Report Form

IEC 60601-1-8 Alarm Systems Collateral Compliance Report Form

 

Regulatory Agencies:

Food and Drug Administration (USA)

    Center for Devices and Radiological Health (CDRH)

    FDA Recognized Standards

Medicines and healthcare Products Agency  (former MDA-UK)

PR China State Food and Drug Administration (SFDA)

China CQC Certification (China Compulsory Certification CCC)

 

Medical Device Regulatory Information:

Code of Federal Regulations (CFR– US)

Medical Devices Directives (MDD-European Union)

    MDD Guidance Documents

    MDD Harmonized Standards

    Answers to YOUR Questions About The Directives

In-Vitro Medical Devices Directive (IVMDD-European Union)

     IVMDD Harmonized Standards

National Institute of Health Sciences (Japan)

Global Device Registration Information

Global Harmonization Task Force (GHTF)

 

Standards Development Organizations:

AAMI (Association for the Advancement of Medical Instrumentation)

CEN (European Committee for Standardization)

CENELEC (European Committee for Electrotechnical Standardization)

ISO (International Organization for Standardization)

IEC (International Electrotechnical Commission)

    SC 62D (Particular Device Standards) Information

    SC 62A (General Device Standards) Information

Standards Administration of China

 

Product Testing and Certification:

Medical Electrical Compliance Associates (MECA)

O’Brien Compliance Management

Underwriters Laboratories

Canadian Standards Association (CSA)

Creo Quality Systems BLOG

 

Medical Device Development Services:

Integrated Center for Device Development                   

 

General Engineering Information:

Global Power Systems and connections

Global Telephone connections

Echolist Internet Directory

 

                                          

 

 

 

 

 

 

 

 

Legal & Regulatory Services:

The Law Offices of Michael A. Swit

Medapprove

 

VDE (German National Standards Body & Device Certification)

Japan Quality Assurance Organization (JQA)

Eisner Safety

QSERVE Consulting

 

Language Translation Services:

Applied Language Solutions

Import/Export Resources:           

     Core Index