Industry Resource Links

This list of resource links and important US and International regulatory organizations below is meant to be a comprehensive list of important industry links that are helpful and useful for our clients. If you find a useful link that would be helpful to others, please email it to us (contact page), and we will try to include it on the list below. Please contact our webmaster by clicking here if any of the links below are broken.

FDA Compliance Links

• Food and Drug Administration – www.FDA.gov
• FDA A – Z Index - http://www.fda.gov/opacom/hpchoice.html
• CDRH A – Z Index - http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/topicindex/topindx.cfm
• CBER A – Z Index - http://www.fda.gov/cber/cberac.htm
• CDER A – Z Index - http://www.fda.gov/cder/index/default.htm
• Code of Federal Regulations - http://www.gpoaccess.gov/cfr/index.html
• FDA / Center for Devices and Radiological Health - http://www.fda.gov/cdrh/index.html
• Recent CDRH Federal Register Notices - http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm
• Medical Device Reporting Search - http://www.fda.gov/cdrh/index.html
• FDA Regulated Industry Information - http://www.fda.gov/oc/industry/default.htm
• FDA Regulatory Procedures Manual - http://www.fda.gov/ora/compliance_ref/rpm/default.htm
• FDA Guidelines Relevant to GMP Compliance - http://www.gmp1st.com/comgl.htm
• Quality Systems Inspections Technique (QSIT) - http://www.fda.gov/cdrh/gmp/gmp.html

ISO Compliance Links

• International Organization for Standardization - http://www.iso.ch/
• RAB – Registrar Accreditation Board – http://www.rabqsa.com/
• Independent Association of Accredited Registrars – http://www.iaar.org

European Links

• The official Website of the European Union - http://www.eurunion.org
• European Committee for Standardization (CEN) – http://www.cenorm.be
• European Confederation of Medical Devices Associations  - http://www.eucomed.be
• Eur-Lex (search for EU documents) - http://www.europa.eu.int/eur-lex/en/search/index.html
• Medical Devices Agency (U.K.) - http://www.medical-devices.gov.uk

Other Links

• International Electro-technical Commission (IEC) – http://www.iec.ch
• Canadian Standards Organization (CSO) – http://www.csa.ca
• Health Canada - http://www.hc-sc.gc.ca/dhp-mps/md-im/index_e.html
• European Committee for Electro-technical Standardization (CE NELEC) – http://www.cenelec.be
• DeviceLink (source of industry information) – http://www.devicelink.com
• Glossary of medical terms - http://allserv.rug.ac.be/~rvdstich/eugloss/welcome.html
• Regulatory Affairs Professional Society - http://www.raps.org/s_raps/index.asp
• American Society of Quality - http://www.asq.org