Information for Regulatory Compliance and Business Performance Improvement
Medical Device Process Validation....
...Classification, EU & FDA regulation, medical device manufacturing. design, medical
device process improvement....
If involved in the design and manufacture 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 update MDD 2007/47/EC.
Below are details of an informational presentation on medical device regulations,
the FDA validation requirements, etc. from design through to manufacturing release.
Introduction to the US FDA and EU Medical Device regulatory requirements
Overview of the key International standards relevant to Medical Devices
How to the classify Medical Devices
Review of current Good Manufacturing Practices (cGMP's)
What are the key components of an effective Quality Management System
How to implement Medical Device Process Validation
Software Validation for Medical Device products and processes
Implementation of a compliant Medical Device design and development process
The Life Cycle Approach to Validation
Implementing an on-going revalidation process
Creating a comprehensive Validation Master Plan (VMP)
How to perform a Validation Gap Analysis
How to identify the need for Validation based on identifying and quantifying Risk
Planning, documentation and reporting validation protocols
How to perform effective auditing to ensure Validation compliance