Impact on Development and Testing Strategies
This webinar will discuss recent changes in the regulatory requirements for medical devices, bringing together the key elements of regulatory strategy and testing limitations to provide an overview of what must be done in the development process, including any relevant time frames and associated costs.
Our speakers will begin with an overview of the current state of the medical device industry as it consolidates during a time when the market is expanding with unparalleled opportunities for the invention of new devices. These changes coincide with heightened requirements for safety assessment and portfolio submission for any new device; therefore it is important to understand both the changes and their effect on the industry as a whole.
As part of the discussion on how these recent changes in registration will affect the companies developing medical devices, we will also cover risk assessments, safety dossier preparation, and any laboratory testing necessary to determine the safety profile of the device.
Finally, our speakers will summarise the testing strategies for medical devices which are tiered and well documented in both the United States and the EU dependent on the potential harm, dwell time, and invasiveness of the product in question. Also included will be an overview of the global regulatory differences and the importance of knowing and understanding the impact of these differences before determining any testing strategies.
It is crucially important to understand the changing requirements and testing strategies in order to develop new timelines rather than relying on past processes for your device development. Join us to understand in depth the recent changes and their impact on your medical device development portfolio.
Statement:
Patient Guard Ltd and Wickham Laboratories Ltd are independent companies collaborating on ad hoc projects and the co-presenting of this webinar is not an indication of partnership.
Presented by
David Small,
Medical Device Consultant
David Small is a principal consultant at Patient Guard Ltd, providing Regulatory and Quality Assurance expertise to Medical Device companies.
He has worked in industry for 5 years as a Project Leader in Medical Device development and Quality Assurance. Prior to his industry career he worked at the MHRA for 2 years as a Higher Medical Device Specialist and before that as a Biomedical Scientist in the NHS.
David is a named inventor for a Medical Device US patent and has degrees in Analytical Chemistry, Analytical Bioscience/Drug Design and a bachelor’s degree in Biomedical Science.
Aaron Lloyd,
Toxicology Laboratory Manager
Aaron Lloyd first joined Wickham Laboratories as an Animal Technician in 2001 and was subsequently promoted over the years to varying levels of responsibility within the department.
Currently, he acts as the Laboratory Manager for Toxicology and In Vitro Research, with oversight of the company's medical device project licenses for USP Plastics Class I-VI and the ISO 10993 series.
His degree was gained at the University of Portsmouth in 1999 in Biology, with specific areas of study including Parasitology, Immunology, Evolution, Animal Diversity, and Marine Biology.
