Medical Device Validation, Regulation, Compliance.

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Medical Device Validation – Regulations, Requirements & Current Practices for Medical Devices.
If you are involved in the design, manufacture, processing and use of medical device products, you will need to fully understand the various medical device regulatory requirements and international standards, e.g. FDA Process Validation requirements, ISO 13485, ISO 14971, etc.. To permit the sale of medical products throughout the European market you will need to understand the medical device regulations such as MDD 93/42/EEC and it’s more recent updates.

Validation includes:
Life Cycle Approach to Validation.
Product and Process Design Validation
Quality Assurance requirements related to Validation compliance.
Risk driven Validation
Current Good Manufacturing Practices
Software Validation practices
Medical device classification
Re-Validation processes
Validation Master Plan
Validation Gap Analysis
Protocol Reporting

 
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