Rick Wedge

Rick has spent nearly 25 years developing medical devices, diagnostics, and combination products since graduating with a degree in applied biology and a PhD in electrochemical biosensors. This has involved the development of prototype products in the laboratory, design and qualification of production instrumentation, establishing quality management systems, and submission of regulatory documentation. Products developed include blood cholesterol monitoring kits, illuminated endoscopes, and drug delivery devices.
Since joining Pfizer’s Devices Centre of Excellence (DCoE) in 2016, Rick has been responsible for managing a team of subject matter experts concerned with the development and implementation of design control and risk management processes for both simple and complex drug delivery devices. Rick’s team works closely with designers, manufacturers, QA and Regulatory (both internally and externally) to ensure that products reaching the market are safe and effective for their intended use. In addition to the above Rick is a member of the working group responsible for authoring ISO 14971 and ISO/TR 24971 and is a wider contributor to the combination products community.