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Electronic Product Development Questions answered for a LOW COST, FIXED FEE -- > Click here Free Links to Medical Device Development Resources This page contains information relevant to the development of Medical Device Products. White papers on medical device product design and testing [stay tuned: this section still under construction] Sample design control documents and templates [stay tuned: this section still under construction] FDA Center for Devices and Radiological Health (CDRH) www.fda.gov/cdrh/ - home page for FDA devices Other Government Regulatory Agencies - European Union: European Commission http://ec.europa.eu/atoz_en.htm - Main Page http://ec.europa.eu/enterprise/medical_devices/index_en.htm - Medical Devices - Japan : Ministry of Health, Labour and Welfare http://www.mhlw.go.jp/english - Main Page - Canada: Health Canada http://www.hc-sc.gc.ca/index_e.html - Main Page http://www.hc-sc.gc.ca/dhp-mps/index_e.html - Drugs and Health Products - Australia: Therapeutic Goods Administration http://www.tga.gov.au/index.htm - Main Page http://www.tga.gov.au/devices/devices.htm - Medical Devices Other sites for information on medical devices and quality systems http://www.ghtf.org/documents/ - Global Harmonization Task Force (GHTF) guidance documents on various medical quality system topics http://www.601help.com - information on 60601 and related standards http://www.devicelink.com/mddi/ - MD&DI magazine website (articles with techniques and tips for medical device product development) Information on standards - International Organization for Standardization (ISO)NOTE: These sites were validated in July 2010. If you find any links that do not work, please report them to the webmaster at carl@angotti.com |
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