Richard Love

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 commercialisation 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 is an Exemplar Global certified ISO 13485/9001 Lead Auditor and has extensive experience with EU, UK, US and Canadian regulations, as well as expertise with MDSAP auditing requirements and specific QMS and regulatory requirements in many key global markets. Richard, a US citizen with UK permanent residence status, started 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.