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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

www.fda.gov/cdrh/qsr/contnt.html - FDA Quality System Regulation (QSR)

 www.fda.gov/cdrh/cdrhlearn/ - FDA instructional material for medical device industry professionals

 www.fda.gov/RegulatoryInformation/Guidances/ucm122044.htm - FDA guidance documents

 http://www.fda.gov/MedicalDevices/Safety/default.htm  - FDA information on recalls, alerts and other safety issues

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)

- International Electrotechnical Commission (IEC)

- American National Standards Institute (ANSI)

- American Society for Testing and Materials (ASTM)

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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