Matthew Theobald – Quality Factors Director

Matthew’s drive is in helping people understand Quality Management and Human Factors, increasing their effectiveness wherever they’re used. His focus on guiding, implementing and supporting compliance activities evolved into Three Circles process for Quality Factors. Matthew ensures that quality and regulatory requirements support the development of medical devices and combination products that meet users’ and regulators’ needs.

“All too often Quality & Regulatory matters are seen as an overhead, getting in the way of creativity and development. In reality they make good business sense and help develop products that work reliably. I believe a good process flexes to suit specific project needs. As with all projects, taking the time to define what you are going to do and how, is far cheaper than trying to fill gaps and remedy mistakes just prior to registration and launch.”

“Documentation should bring value to device development and not just be a tick in the box exercise”

Matthew has over 20 years experience working at strategic, site and project levels with organisations across Europe and the US. He has worked in both medical device development and Quality Management. Matthew has presented at conferences throughout Europe, delivered more than 50 training events, co-authored the book “How to Build an Ark: Project Management for the 21st Century” and is a contributing author to several ISPE Guides.

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