


Standards and Regulatory Agencies:
U.S. Food and Drug Administration
» www.fda.gov
Center for Devices and Radiological Health (CDRH)
» http://www.fda.gov/cdrh/
Office of Device Evaluation (ODE)
» http://www.fda.gov/cdrh/ode/index.html
Office of Combination Products
» http://www.fda.gov/oc/combination/
Office of Orphan Products Development
» http://www.fda.gov/orphan/
CDRH Databases
» http://www.fda.gov/cdrh/databases.html
CDRH Device Advice
» http://www.fda.gov/cdrh/devadvice/
ASTM International (originally American Society for Testing and Materials)
» www.astm.org
International Organization for Standardization
» http://www.iso.ch/
American National Standards Institute (ANSI)
» http://www.ansi.org/
» http://www.aami.org/standards/about.html
Association for the Advancement of Medical Instrumentation
» www.aami.org
International Electrotechnical Committee (IEC)
» http://www.iec.ch/
Clinical and Laboratory Standards Institute (Formerly, NCCLS – National Committee for Clinical Laboratory Standards)http://www.nccls.org/
» http://www.clsi.org/
Medical, Professional & Research Societies:
The American College of Cardiology (ACC)
» http://www.acc.org/
Society for Biomaterials
» http://www.biomaterials.org/
The Society for Cardiac Angiography and Interventions
» http://www.scai.org/
The American Heart Association (AHA)
» http://www.americanheart.org/
The VascularWeb.org
» http://www.vascularweb.org/
The American Academy of Orthotists and Prosthetists
» http://www.oandp.org/
The American Society of Mechanical Engineers (ASME-BED)
» http://www.asme.org/divisions/bed/index.html
The American Society of Biomechanics (ASB)
» http://www.asb-biomech.org/
The American Society for Bone & Mineral Research
» http://www.asbmr.org/
The Biomedical Engineering Society (BMES)
» http://www.bmes.org/
The Society for Biomaterials (SFB)
» http://www.biomaterials.org/
The Orthopaedic Research Society (ORS)
» http://www.ors.org/
Transcatheter Cardiovascular Therapeutics (TCT)
» http://www.tctmd.com/
The North American Spine Society (NASS)
» http://www.spine.org/
The World Spine Society (WSS)
» http://www.worldspine.org/
Commercial Services
Bose ElectroForce
» www.bose-electroforce.com
Regulatory Consulting Services
CardioMed Device Consultants, LLC - Gambrills, MD
» http://www.cardiomedllc.com/
Regulatory, Clinical and Technical Contract Services to the Medical Device Industry Paladin Medical, Inc. - Minneapolis, MN
» http://www.paladinmedical.com/
Design, Analysis and Prototypes ECHOBIO - Bainbridge Island, WA
» http://www.echobio.com/
Exper Advocates in Finite Element Analysis & Fatigue Characterization of Medical Devices - Amicus Engineering, Inc. - San Jose, CA
» http://www.amicusengineering.com/
