.... 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



















For those individuals involved in the development and manufacture of medical devices, there is a need to implement continuous improvement processes.


Remaining up to date with regulatory requirements, and ensuring you have a comprehensive knowledge of not just regulatory demands but also an understanding of continuous improvement approaches can be costly and time consuming.


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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