FDA medical device audits
CAPA
ISO 13485
ISO 13485 matrix
ISO 14001
Professional links 1
Professional links 2
About/contact us
Alpha Quality Assurance provides these professional links as a service to the medical industry
Alpha Quality Assurance Associates 111 Nataqua Avenue Pacifica, CA 94044 Phone 650.359.4297 Fax 650.359.6171 kenmiles@alphaqa.biz .
Regulations:
Title 21 Code of Federal Regulations
Medical Device Directive (93/42/EEC) Text
In Vitro Diagnostic Medical Device Directive (98/79/EC) Text
Directive as regards medical devices incorporating stable derivates of human blood or human plasma (2000/70/EC)
Notified Bodies:
List of Notified Bodies
KEMA
TÜV Rhineland
NSAI (National Standards Authority of Ireland)
TÜV SÜD
BSI
Standards and Guidance:
FDA Recognized Consensus Standards Database
List of Harmonized Standards
Global Harmonization Task Force
International Organization for Standardization
Professional Societies:
Regulatory Affairs Professional Society
American Society for Quality
Medical Device Testing:
CITECH—Mechanical and electrical safety and performance testing
Alpha Quality Assurance 111 Nataqua Ave Pacifica, CA 94044 650.359.4297 info@alphaqa.biz
2006 Alpha
Quality Assurance