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Training:

MediSem, Inc. (Public and in-House Seminars for Medical Devices and Related Industries) www.medisem.com

Key Medical Devices
and Healthcare Contacts:

Assoc. for the Advancement of Medical Instrumentation www.aami.org
Regulatory Affairs Professionals Society www.raps.org
American Society for Quality www.asq.com
Process Management Quality Group www.pmqgroup.com

European Sites:

Europa (EU On-line) europa.eu.int/index_en.htm
European Commission www.europa.eu.int
CEN www.cenorm.be
CENELEC www.cenelec.org
European Diagnostic Manufacturers Assoc. www.edma-ivd.be
NSAI (Notified Body) www.nsai.ie
Irish Medicines Board (Competent Authority) www.medicaldevices.ie
European Medical Technology Industry Assoc. www.eucomed.be

International Sites
and Government Agencies:

Food and Drug Admin., USA www.fda.gov/cdrh/index.html
Standards Council of Canada www.scc.ca
Health Canada www.hc-sc.gc.ca/english_index.html
Japan National Institute Health Sciences www.nihs.go.jp
Japan Ministry of Health, Labour and Welfare www.mhlw.go.jp/english/
TGA Australia www.health.gov.au/tga
Regulations for China www.ita.doc.gov/td/mdequip/chinaregs.html
Regulations for South Korea www.ita.doc.gov/td/mdequip/korearegs.html
NSAI (North American Operation) www.nsaicert.com
Global Harmonization Task Force www.ghtf.org