Medical Devices: How to Validate a Medical Device …

The design, manufacture, processing of medical devices, demands a full understanding of 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, updated via MDD 2007/47/EC. How are medical devices classified? How do you integrate risk into the validation process? How do you perform a validation gap analysis? How is validation effectively performed during product design? How to validate a medical device containing software? Etc., etc.

770 pages of information which is updated on an on-going basis as new information comes available, or as recommendations are received from users. Use to enhance your personal understanding or use to train and inform your work peers. Currently covers the following topics:
 

♦ 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

 

Further details on how to Validate a Medical Device, regulations, requirements, risk integration, etc.,    ….