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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)
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
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