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Home Clinical Studies Medical Devices Part11 Quality Systems Regulatory Canada



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Industry Sector News
- Orion Registrars Cessation as
CMDCAS Recognised Registrar by Health Canada
- Health Canada Issues Private
Label Medical Device Guidance and Forms
- FDA Revises Computerized Clinical Trial Systems
Guidance
- FDA Issues Guidance for Orthopedic Device
Clinical Data
FDA ISSUES FY2008 MEDICAL DEVICE USER FEE SMALL BUSINESS GUIDANCE
- GHTF
Releases proposed guidance on STED for medical devices
- FDA Part 11 Enforcement Resumes: Return of
Audit Trail Requirement
- Japan to
require ISO 13485:2003 registration by 1 April 2005
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Orion
Registrars delisted as CMDCAS recognised registrars
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FDA ISSUES FY2008 MEDICAL DEVICE USER FEE SMALL BUSINESS GUIDANCE
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FDA Postpones 2008 Establishment Registration
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FDA Proposes Reinspection Fees
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