.... Understand the essentials of Medical Device Validation.

Medical Device Design, Manufacture, Processing, Release to Customers, Product  Use Feedback

US FDA, EU MDD requirements

Statistical and Quality Improvement Methodologies

Validation of Medical Devices

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Details on a 500 page informational presentation on medical device validation >>>

Information on medical compliance, risk, validation >>>

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic Introduction to Validation >>>

Introduction to the PQ, IQ, OQ, etc., stages in Medical Device Validation >>>

 

Related sources of information:

EU Commission opinion on the revision to the Medical Devices Directives >>>

Classification of medical devices , June 2010

MEDDEV 2.4/1 rev.9(654 KB)

 

Medical devices with a measuring function, June 1998  MEDDEV 2.1/5(10 KB)

 

Guidance for Industry, FDA, Process Validation: General Principles and Practices:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm070336.pdf

 

Medical Device Vigilance Manufacturer’s Incident Report Report Form

 Quality Management Systems - GHTF >>>

 

Regulatory requirements of bodies such as the US FDA, or the European Medical Devices must be clearly understood where either you or your peers are involved in the product life cycle of a medical device.

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