Experts who make MedTech compliance feel manageable.

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 (now Emergo by UL).  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 formal training to MDSAP auditing requirements as well as a deep understanding of specific QMS and regulatory requirements in many key global markets. Richard is 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.

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Richard joined MD Compliance after a 30 year career working in different medical device and IVD companies for 15+ years and other consultancy firms such as Emergo, Oriel Stat-A-Matrix and NAMSA for 15 years .

Richard's skill set encompasses Regulatory Affairs and Quality Assurance Compliance with extensive experience in the medical device, in vitro diagnostic, and health care industry. Experiences include compiling regulatory submissions, regulatory strategy for new and novel products, performing quality system assessments, and supporting audits/inspections of quality systems. Manages teams of individuals, mentoring and coaching on regulatory requirements, training on regulatory topics, and supporting compliance with regulations. Specialized in global Quality Systems Regulations with expertise in submission content, regulatory classifications, risk management, software-driven products, post-market surveillance, complaint handling, adverse event reporting, inspection readiness, and auditing.

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Brian is a Biomedical Engineer with deep experience of medical device development and medical device regulations, consulting to a wide range of medical device companies on regulatory compliance, with specific interest in Software as a Medical Device (SaMD). 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 and his specialities include SaMD, software lifecycle development management, EU MDR  and electro-medical devices (IEC 60601).

With over 13 years of experience in Quality Management Systems (QMS), Rebecca has built a strong reputation for supporting medical device Organisations in achieving and maintaining regulatory compliance and operational excellence. Her expertise spans ISO 13485, European and USA FDA requirements, with particular strength in aligning quality systems to meet both regional and international standards.

Rebecca has extensive experience in the implementation and optimisation of ISO 13485-compliant QMS frameworks, across both small to mid-sized organisations. She is highly skilled in conducting internal and supplier audits, driving continuous improvement initiatives, and ensuring robust audit readiness across all levels of the business.

Her technical expertise includes ethylene oxide (EO) sterilisation processes (ISO 11135), environmental and contamination controls, and structured problem-solving methodologies. A passionate advocate for quality culture, Rebecca provides coaching and guidance to teams and leaders, embedding practical, sustainable quality practices that support long-term organisational success.

Toni – founder of our valued partner, Regulatory Insights Ltd – brings over two decades of regulatory expertise to our team. With deep experience in developing and executing regulatory strategies for complex and novel medical technologies, including AI, software as a medical device (SaMD), biologics, and in vitro diagnostics (IVDs), Toni is a trusted expert in navigating challenging regulatory landscapes. Her background spans the full product lifecycle—from early-stage design and development to successful market approval—with a focus on high-innovation, fast-paced environments. She has a strong command of global regulatory frameworks, including ISO 13485, 21 CFR Part 820, and EU MDR/IVDR (2017/745 and 2017/746), and is highly experienced in leading medical device clinical trials in compliance with ISO 14155, 21 CFR Parts 50, 56, and 812, and GCP.  Her clinical work includes protocol development, statistical sampling plans, IRAS submissions, and FDA pre-submissions and IDE filings. Toni’s impact in the medical devices industry has been widely recognised—she was part of the team that was named a Finalist for the Royal Academy of Engineering’s MacRobert Award in 2019, and ultimately a Winner in 2025. She also serves as a BSI committee member for medical device labelling and standards and is a named author on multiple patents, posters, and publications. Toni holds a DPhil in Molecular Neurobiology from the University of Oxford, a BSc in Biochemistry from the University of Warwick, and several additional qualifications from the University of Oxford in statistics, management, and entrepreneurship.

Andrew is a PhD-qualified bioengineer and mechanical engineer with over 30 years of experience in the development, technical documentation, and regulatory approval of high-risk implantable medical devices. His expertise spans orthopaedics (arthroplasty, extremities, trauma, CMF, spine, and sports medicine), cardiovascular technologies (heart valves, LVADs, vascular implants), and active implantable devices (neurostimulation). He has particular depth in implant systems, advanced biomaterials, bioactive coatings, and minimally invasive surgical platforms.

He has served as project leader and senior technical contributor on multiple EU Class III implant programs, including regulatory up-classification initiatives and full EU MDR transitions. Andrew has extensive experience preparing and defending technical documentation for Notified Body review, including Clinical Evaluation Reports (MEDDEV 2.7/1 Rev 4), risk management files (ISO 14971), biocompatibility assessments (ISO 10993) and US FDA Design History Files.

Andrew combines deep biomechanical and biomaterials expertise with practical regulatory execution. He has led cross-functional development teams from early design specification through verification, validation, and market launch, interfacing directly with surgeons, notified bodies, regulatory authorities, and multinational stakeholders. His background includes senior R&D roles at DePuy (Johnson & Johnson) and over 20 years of consultancy advising global manufacturers, SMEs, and start-ups on product development strategy, regulatory submissions, and MDR compliance.

A qualified ISO 13485:2016 Lead Auditor (TPECS), Andrew brings strong technical authority, regulatory judgement, and structured leadership to complex, high-risk device portfolios.

Colin's first experience in the sector was as Finance Director of an AIM quoted medical devices group back in 2000. He subsequently ran Mediqol before its acquisition by Emergo where he stayed and led their European business for 7 years. He left the medical devices arena in 2018 to run a software and laboratory business but returned when he joined NAMSA in a senior Business Development role in 2021. He has experience of global medical device registrations and particularly enjoys working with early stage medical device companies to help them develop and then implement their regulatory and clinical strategies.

Bryan joined MD Compliance in 2025 after 28 years with Corza Medical (previously Katena Products, Inc.) Over the years, Bryan held several senior management positions, including Vice President of Operations and Vice President Quality Regulatory. Earlier in his career, Bryan worked at Stryker Corporation where he was first introduced to multiple quality standards, regulations, and the requirements for CE mark authorization within the European Union.

With more than 35 years in the medical device industry, Bryan has progressively expanded his Quality Assurance and Regulatory Affairs expertise within quality engineering to executive leadership roles, ensuring compliance with complex global regulatory requirements as both organizations broadened their international market presence. Bryan is highly skilled in QMS compliance, global regulatory strategy, and auditing expertise in ISO 13485, MDSAP, US FDA 21 CFR §820, EU MDR/IVDR, FDA CBER 21 CFR §1271 (HCT/P Tissue) and ISO 14971. Bryan has a proven track record as lead auditor, design control systems, and leading comprehensive QMS transitions aligned with evolving global regulatory frameworks to drive continuous improvement. Bryan has held leadership responsibility for regulatory compliance across major global jurisdictions including  the United States, Japan, Brazil, Australia, New Zealand, Saudi Arabia, UAE, Argentina, South Africa, Kuwait, Dubia, Egypt. In addition, he has conducted multiple M&A due diligence assessments and led Quality Management System, operations and product integrations of acquisitions involving three private equity firms ensuring seamless regulatory and operational alignment post-transition.

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Tina started her career at the MHRA before moving into consultancy with Emergo in 2004.

Over twenty years of experience in medical device regulatory and clinical affairs working with numerous clients, from multi-national corporations to SMEs, which manufacture products varying from low risk to high risk medical devices. Experience includes (not limited to) technical documentation compilation, technical documentation gap analyses, generation of clinical evaluation plans and reports,  support with PMS and PMCF activities and provision of general regulatory support.  Product experience across cardiovascular, orthopaedic and dental implantable technologies, instruments, wound dressings, filtration products and other therapeutic devices.

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Sarah has worked in the medical device industry since 2000, beginning her regulatory career with DePuy CMW before joining Emergo in 2006. During her time at Emergo, she gained significant experience working with a wide range of manufacturers, including those producing high-risk devices.

She has extensive experience with CE Marking, FDA submissions, and global regulatory approvals for Class I, IIa, IIb and Class III orthopedic devices. Her therapeutic expertise spans bandages and supports, creams and emollients, gynaecology, cardiovascular devices, wound care, medical filtration, urology, and general surgical devices. This work has included (but not limited to) the preparation of technical documentation in compliance with European MDD and MDR requirements, conducting gap analyses, compiling clinical evaluation reports (including literature searches), reviewing labelling, contributing to risk management processes, supporting PMS activities, and providing broader ad hoc regulatory support.

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