Richard Love PCQI
Principal Consultant
Richard has worked in the medical devices industry since 1991, first gaining regulatory knowledge through roles with increasing responsibility at several start-ups/SMEs involved in research, development and commercialization of Class I, II (IIa) and III cardiovascular medical devices. Richard began his consulting career in 2006 with Experien Group (now Veranex), followed by over 8 years as a Senior Consultant at Emergo. He holds Practitioner grade qualification from the Chartered Quality Institute (CQI), memberships with the American Society for Quality (ASQ) and the Organisation for Professionals in Regulatory Affairs (TOPRA), and is an Exemplar Global-certified ISO 13485 and ISO 9001 Lead Auditor. Richard has extensive experience with EU, UK, US and Canadian regulations, along with expertise of MDSAP auditing requirements and specific QMS and regulatory requirements in many key global markets. Richard, a US citizen with UK permanent residence status, founded MD Compliance Ltd in 2015 and holds a degree in Philosophy from Regis University and has also studied Business Administration in both California and Scotland.
Brian Goemans
Senior Regulatory Consultant
Brian is a Biomedical Engineer with deep experience of medical device development and medical device regulations. Brian has been consulting to a wide range of medical device companies on regulatory compliance, with specific interest in Software as a Medical Device (SaMD). Consulting customers include MD Compliance and Emergo (and their customers), BrightInsight, Amgen, and South African companies. Brian compiles Technical Files for CE marking, writes Clinical Evaluation Reports (CER), and compiles FDA 510(k) submissions. Brian is also active in IEC standards development. Brian’s specialities include SaMD, software lifecycle development management, MDR / IVDR, and electro-medical devices. Brian holds an MSc in Biomedical Engineering from the University of Cape Town, and BSc Eng in Electrical Engineering from the University of the Witwatersrand.
Rebecca Swindell
Quality & Regulatory Consultant
Rebecca joined the medical device industry in 2013 after completing her degree, achieving a BSc in Biology from The University of Hull. Her career in the industry has taken her through several Quality and Regulatory roles in medical device manufacturing, having been responsible for implementing EU, UK, US, and Canadian regulatory requirements. Most recently she held the position of Quality Manager for a global leader in medical device sterilisation, ensuring ISO 11135 compliance and championing Quality Culture within the organization. Rebecca is an ISO 13485 qualified Lead Auditor and holds a Diploma in Management, including Project Management and Leadership. Rebecca joined MD Compliance in 2022 and has led on multiple QMS projects which are individually tailored to support our clients’ needs, as well as providing significant contributions to MDR and US FDA regulatory projects.
David Frame
Senior Quality & Validation Consultant
David is a highly accomplished senior Quality professional with over 20 years of experience driving business improvements and operational excellence in the medical device and IVD industry. He has a proven track record in leading international teams, implementing robust Quality Management Systems (QMS), and ensuring compliance with various regulatory requirements. David is skilled in computer systems validation, process/product validation, audit/inspection management, vendor management, and more. He has worked with renowned companies like Abbott, Alere, and Haemonetics, and is passionate about continuous improvement and maintaining the highest quality standards in the industry.
David Francis
Senior Regulatory Consultant
David is a highly experienced regulatory affairs professional and engineer with a deep expertise in medical device development, certification, and regulatory compliance. With a career spanning over 25 years, David has worked extensively with medical devices and active implantable medical devices, offering consultancy and certification services to a wide range of medical device manufacturers globally. David served as the Head of Approved Body and Product Reviewer at LNE-GMED UK Ltd and as Certification Lead at Scarlet Notified Body. He has previously held senior roles in regulatory affairs, including Director of Regulatory Affairs at ICON plc (formerly MedPass International). He has also held senior roles at TÜV SÜD, Lloyd's Register, and BSI Group, conducting technical reviews, audits, and certifications for a range of medical devices, including active implants, cardiovascular devices, and drug-device combination products. His specialties include device classification, route-to-market strategies, clinical evaluation plans/reports, risk management, PMS/PMCF plans, technical file construction & gap analysis, liaison with Notified Bodies and Competent Authorities, due diligence work and technical audits. David is registered as a European Engineer with the European Federation of National Engineering Associations (FEANI), also as a Chartered Engineer with the Engineering Council in the UK, a Fellow of the Institution of Mechanical Engineers and Member of the Institution of Engineering and Technology (formerly the Institution of Electrical Engineers).
Andrew Donn
Senior Regulatory Consultant
Andrew holds a masters degree in mechanical engineering and a PhD in bioengineering. He brings broad-based, international medical device business experience and has spent over 30 years delivering product development projects in compliance with to ISO 13485 and within major international regulatory frameworks (USA– FDA,EU–CE Marking and Japan–MHLW/PMDA). Andrew has advanced product development, regulatory affairs, bio engineering, design, research and analysis skills, coupled with extensive project management experience and a strong customer focus and the ability to interface effectively with internal and external stakeholders.
Christine Park
Senior Quality Consultant
Christine is a solution-focused and results-oriented consultant with extensive Business Development/Quality Systems/Regulatory Affairs experience. She has proven success and business acumen to integrate quality into daily business activities while reducing costs. She utilizes a pragmatic, common sense approach to defining and establishing good business practice to achieve goals with quality and assurance to regulatory compliance. Her experience in the R&D or general manufacturing arena for the Medical Device, IVD, and Biotech/Pharmaceutical, food and cosmetic environment leads to successful integrated management systems in industry. She is an active member of the ISO TC210 Technical committee for the development of ISO 13485, 14971 (risk management), 24081 and 20416 (post market surveillance). Christine is based in the United States.
Giulia Paggiola
Quality & Regulatory Consultant
Giulia brings over 12 years of experience in the life sciences industry. Starting her journey with a PhD in Chemistry and early career in corporate Pharma R&D, she then transitioned to supporting medical device startups since 2017. Giulia's expertise spans regulatory strategy, clinical affairs, quality compliance, and post-market surveillance, focusing primarily on the demands of US and EU markets. Her portfolio includes Software as Medical Device (SaMD), combination devices, and active invasive devices. Giulia is highly familiar with the challenges faced by medtech startups. She's had direct experience of integrating Quality Management System requirements within Agile software development, designing effective regulatory strategy for complex unconventional products under budget constraints, and establishing the right Quality governance structure for fast-growing organisations, including in dual consumer-medical businesses. Giulia is based in Switzerland and speaks English, Italian, Portuguese, German and Spanish.
