Rod brings a wealth of worldwide regulatory knowledge and quality assurance experience to companies wanting to design, manufacture, and market compliant medical devices.
Rod has a bachelor’s degree with first class honours in engineering and management. He also holds the prestigious Regulatory Affairs Certification (Global Scope) from the Regulatory Affairs Professionals Society and is a Lean Sigma Green Belt. Rod has worked in the medical device and pharmaceutical industry for over 23 years, including time spent in some of the largest medical device and pharmaceutical manufacturers.
Rod’s experience has involved providing regulatory strategy from product development to worldwide market registration, creation of technical documentation, implementation of full 13485 compliant QMS systems, standards compliance, clinical evaluations, risk management files, project management and remediation activities. Rod has also spent time working for a notified body, conducting audits against ISO 9001, ISO 13485, 21CFR820, MDSAP, cGMP and GDP.
Rod’s device experience covers Class I, II and III devices, including software as a medical device, drug delivery devices, IVDs, and active implantable medical devices. More recently, Rod has helped clients update their clinical evaluation processes to the requirements of the MDR, updating risk management systems to the latest standard and delivering training on MDR, IVDR, clinical evaluation, risk management, MDSAP and QMS systems.