Teresa Perry
Owner
With nearly 30 years of experience in quality and regulatory affairs, Teresa has been instrumental in shaping the industry.
Her career spans pivotal roles in securing accreditations, influencing regulatory policies, and guiding manufacturers through some of the most complex transitions in medical device history.
Key Achievements
LNE-GMED UK: As Head of Approved Body, Teresa led a dedicated team in implementing ISO/IEC 17065 and ISO/IEC 17021-1, securing critical designations under UK MDR 2002 Parts II, III, and IV. Through collective expertise and commitment, they enabled UKCA marking for both medical and non-medical products.
Regulatory Leadership: Teresa’s guidance positioned LNE-GMED UK as a founding member of Team-AB, shaping UK regulatory policies and achieving critical location status for GMED. She also facilitated the first-ever Innovative Device Access Pathway (IDAP) assessment in collaboration with the MHRA.
BSI: During her 20-year tenure at BSI, Teresa held key operational and leadership roles in auditing, CE Mark ophthalmic scheme management, certification, and global management. She was at the forefront of major regulatory shifts, including MDR, IVDR, MDSAP, and COVID-19 business continuity planning.
Industry Experience: Teresa’s hands-on experience in the contact lens manufacturing sector during the introduction of the original Medical Device Directive gives her a unique perspective on the challenges manufacturers face.
David Francis
Consultant
With over 25 years of experience in engineering, regulatory affairs, and quality management, David has played a pivotal role in the medical device industry, particularly in active implantable medical devices, software certifications, and regulatory strategy. Throughout his career, David has led teams, managed complex projects, and provided expert guidance on regulatory compliance, helping manufacturers navigate some of the industry’s most critical challenges.
Key Achievements:
- LNE-GMED UK Ltd: As Deputy Branch Director and Product Reviewer for Active Implantables & Active Devices, David provides regulatory expertise across medical devices and other technical products. His work includes acting as a decision maker and competence verifier within his areas of expertise, while contributing to the organization’s business development at a group level.
- Scarlet Notified Body B.V.: David’s role as Certification Lead involves reviewing and making decisions on the certification of software and AI medical devices under the applicable regulations. His experience ensures that all regulatory requirements are met, maintaining the highest standards for product safety and compliance.
- ICON plc (MedPass International): David has held multiple leadership positions in regulatory affairs, where he delivered strategic consultancy on the regulatory pathways for medical devices and drug-device combination products. He was instrumental in providing regulatory support for clinical trials, risk management, and developing strategies to navigate EU and global market access.
- BSI Group: As Global Head of Active Implantable Devices, David led the regulatory and quality management reviews for implantable medical devices, guiding companies through the CE marking process and ensuring compliance with the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD). He has been recognised for his technical expertise and leadership in the field.
Extensive Industry Experience: David’s hands-on experience spans a range of device types, from cardiovascular implants like pacemakers and defibrillators to drug-coated angioplasty balloons and spinal devices. He has also contributed to the development of regulatory frameworks and played a key role in device approvals and market access.
Anthony S Webb
Consultant
Meet Anthony S Webb, an international legal counsel with a wealth of experience spanning over three decades. His primary focus lies in navigating the intricate realms of medical device regulation and corporate law. With an unwavering commitment to effective risk management and strategic legal counsel, Anthony has established himself as a trusted advisor on matters pertaining to EU and UK legislation, including the cutting-edge domain of AI compliance.
Drawing from his extensive background at a prominent international law firm in London’s esteemed City district, as well as his tenure as in-house counsel for a multinational UK corporation, Anthony possesses a deep understanding of the complex regulatory landscape governing medical devices in Europe and the United Kingdom. His expertise encompasses advising on pivotal European legislation, such as the Medical Device Regulation, and his involvement in establishing the first notified body for AI compliance underscores his forward-thinking approach.
As a seasoned anti-money laundering and data protection officer, Anthony has demonstrated his ability to implement robust risk management strategies and legal frameworks tailored to the unique needs of global clients. His enthusiasm for driving regulatory improvements and his openness to exploring innovative solutions within the medical device sector make him a valuable asset to those seeking expert guidance in this dynamic field.
Currently, Anthony operates his own legal consultancy, providing invaluable advice to clients located around the world. Reach out to him at anthony@webbconsultancy.io or +27 68 727 1549 to discuss your specific needs and leverage his extensive expertise. Quote ‘Peritus’ for preferential rates.
Dawn Smiles
Consultant
Peritus Ltd is proud to collaborate with Dawn Smiles and her team of market access and regulatory professionals. This partnership enables us to offer expanded support to clients requiring larger multidisciplinary teams or specialist expertise in market access and adoption following regulatory approval. Running her own successful business as Founder and Clinical Director, Dawn brings a rare combination of clinical insight and commercial strategy. She holds an Honours degree in Biomedical Science, is a Fellow of the Institute of Biomedical Science and has a postgraduate qualification in Advanced Medical Imaging. A fully qualified Vascular Scientist, Dawn has over two decades of award-winning experience across UK, European, and international markets, including roles in sales, clinical education, and business development. Beginning her career as a clinical medical microbiologist in the NHS, Dawn transitioned into the medical technology sector where she has since become a trusted expert in regulatory and quality matters. Her passion for quality and regulatory excellence is a key reason for this partnership and drives our mutual mission to support medical device companies in developing robust technical files, implementing Quality Management Systems (QMS), and navigating a broad range of ISO standards.
Gail Beaton
Consultant
Gail holds an Honours Degree in Industrial Design Engineering and a PhD in Computer Modelling and Biomechanics, for which she received industry recognition and an academic award. She began her career in a start-up environment and, over nearly a decade in the medical devices industry, gained extensive experience in project management and delivery across orthopaedics, cardiovascular, and oncology devices. Gail is a named inventor on several patents, reflecting her hands-on involvement in product innovation and development.
Following her time in industry, Gail spent ten years at BSI, initially delivering regulatory audits and training for global medical device clients. She later managed auditor competence and delivered internal CPD programmes. Progressing into leadership roles, she led multiple transformation projects, including the development of audit software and customer-facing digital platforms.
In her most recent role, Gail was responsible for Customer Experience and led key initiatives to improve the service delivery of client-facing functions. This included the design and delivery of an award-winning digital portal concept that enhanced usability and client engagement.
Gail brings a strong track record in process improvement, training, and quality management system development. Her recent focus has expanded to include service design, usability, and customer experience—supporting clients in aligning operational delivery with user needs and regulatory expectations.
Ava Sainter
Consultant
Ava is a senior quality and regulatory affairs professional with over 12 years of experience in the IVD and medical device industries. She holds strategic leadership roles overseeing regulatory compliance, quality systems, and product development, with a strong track record of driving innovation while ensuring alignment with international standards and regulations such as ISO 13485 and (EU) 2017/746 IVDR. Ava combines technical depth in immunoassay development with high-level regulatory oversight, making her a key leader in bridging scientific development with robust quality and regulatory governance.
Ava’s experience in the development, evaluation and certification of IVD medical devices, brings a unique dual perspective, enabling her to assess product safety and performance with precision while ensuring alignment with evolving UK and EU regulatory frameworks.
Key Achievements:
William Oak Diagnostics Ltd: As Head of Quality and Regulatory Affairs, Ava leads the design and implementation of the organisation’s quality and regulatory strategies, ensuring full compliance with ISO 13485 and meeting the regulatory requirements for UK, EU and US markets. She serves as the company’s Management Representative, guiding QMS development, overseeing technical documentation and regulatory submissions, and ensuring alignment between innovation, quality, and commercial objectives. Ava is instrumental in establishing a culture of compliance, continuous improvement, and operational excellence across departments.
LNE-GMED UK Ltd: As an IVD Product Reviewer, Ava conducted comprehensive assessments of technical documentation under the IVDD and IVDR for CE and UKCA marking. Her responsibilities included evaluating clinical performance data, coordinating with cross-disciplinary teams, and ensuring technical and regulatory consistency across product reviews. She supported the harmonisation of IVD nomenclature and provided IVDR training and internal knowledge transfer across the organisation. Ava also played an active role in the MHRA’s IDAP initiative, producing regulatory gap analyses for manufacturers.
Mologic Ltd: In her role as Project Manager and Biosafety Practitioner, Ava led major diagnostic development projects from concept to market, overseeing laboratory operations, technical design, and risk mitigation strategies. She managed clinical study planning, quality documentation, and technical compliance with ever-evolving regulatory requirements, while also ensuring biosafety compliance across five laboratories. Her consistent technical success and regulatory alignment contributed to securing multiple contracts and generating over £1 million in revenue.
Omega Diagnostics & Genesis Diagnostics: Ava contributed to the research and validation of immunodiagnostic products, including the challenging development of an HIV point of care test. Her work included assay development, performance evaluations, and technical troubleshooting, with a strong focus on QMS, ISO 13485 compliance, and design control principles.
Comprehensive Industry Expertise: Ava is certified in ISO 13485, ISO 14971, and multiple IVDR modules. She holds advanced training in (EU) 2017/746, IVD clinical performance evaluation, labelling, biosafety, and usability engineering (IEC 62366-1). With an MPhil in Biomedical Sciences and a BSc in Biomedical Science, Ava integrates deep scientific expertise with regulatory acumen, ensuring that diagnostic products are developed to the highest standards of safety, performance, and compliance.