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Useful Links
Standards Development Organizations
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Association for the Advancement of Medical Instrumentation (AAMI)
http://www.aami.org/standards/about.html |
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American National Standards Institute (ANSI)
http://www.ansi.org/ |
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American Society for Testing and Materials (ASTM)
http://www.astm.org/ |
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International Electrotechnical Committee (IEC)
http://www.iec.ch/ |
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International Organization for Standardization
http://www.iso.ch/ |
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NCCLS
http://www.nccls.org/ |
U.S. Government
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U.S. Food and Drug Administration (FDA)
http://www.fda.gov/ |
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Center for Devices and Radiological Health (CDRH)
http://www.fda.gov/cdrh/ |
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Office of Device Evaluation (ODE)
http://www.fda.gov/cdrh/ode/index.html |
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Office of Combination Products
http://www.fda.gov/oc/combination/ |
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Office of Orphan Products Development
http://www.fda.gov/orphan/ |
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CDRH Databases
http://www.fda.gov/cdrh/databases.html |
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CDRH Device Advice
http://www.fda.gov/cdrh/devadvice/ |
Professional Services
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Regulatory Consulting Services
CardioMed Device Consultants, LLC - Gambrills, MD http://www.cardiomedllc.com/
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Regulatory, Clinical and Technical Contract Services to the Medical Device Industry
Paladin Medical, Inc. - Minneapolis, MN http://www.paladinmedical.com/ |
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Engineering Consulting Services
Pemstar Pacific Consultants, Inc. - San Jose, CA
http://www.pacificconsultants.com/_mechanical.html
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A Medical Device Consulting Company
CardioMed Device Consultants, LLC - Gambrills, MD http://www.cardiomedllc.com/ |
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FEA Design & Evaluation Services
Pemstar Pacific Consultants, Inc. - San Jose, CA http://www.pacificconsultants.com/
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Design, Analysis and Prototypes
ECHOBIO - Bainbridge Island, WA http://www.echobio.com/ |
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Expert Advocates in
Finite Element Analysis and Fatigue
Characterization of Medical Devices
Amicus Engineering, Inc. - San Jose, CA http://www.amicusengineering.com/ |
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Toll Free 1-866-TESTING (1-866-837-8464) |
Bose Corporation ElectroForce Systems Group |
| 10250 Valley View Road, Suite 113 |
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Eden Prairie, Minnesota 55344 USA |
| 952.278.3070 |
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FAX: 952.278.3071 |
electroforce@bose.com
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