David is the founder and CEO of Patient Guard Ltd and Patient Guard Europe UG. Patient Guard offers UK and EU medical device regulatory and quality support to medical device developers and manufacturers. David has a BSc (hons) in Biomedical Science and an MSc in Analytical Bioscience and Drug Design. Starting off as a Biomedical Scientist specialising in Clinical Chemistry in the NHS, David then moved to the MHRA as a higher medical device specialist, before moving to industry in various quality and regulatory roles. David was also involved in the development of medical devices from an R&D perspective. David set up Patient Guard in 2017 and has seen it grow into one of the leading Medical Device consultancies in the UK. David set up Patient Guard UG in Germany in 2021 to expand the range of services Patient Guard could offer to cover all areas of medical device regulation in the EU. Patient Guard provide the following key services: • UKCA Technical Files to the UK Medical Device Regulations 2002 (as amended) • CE technical Files to MDR 2017/745 and IVDR 2017/746 • Medical Device Risk Management support to ISO 14971 • Biological Evaluation Plans and Reports to ISO 10993-1 • Biological Evaluation Testing (Cytotoxicity, Extractables and Leachables, Skin Irritation, Drug Stability) • Clinical Evaluation Plans and Reports • Post Market Surveillance assistance (Vigilance, PMCF) • UK Responsible Person • EU Authorised Representative • ISO 13485 implementation and management services • Internal Auditing Services With a team of 5 experts we are well placed to support project aspects simultaneously speeding up the compliance process significantly. For more information please visit our website https://patientguard.com