OUR TEAM
MEMBERS
We believe in the power of collaboration and innovation. Our team is a dynamic group of talented individuals, each bringing their unique expertise and passion to the table. Together, we strive to push the boundaries of technology and deliver exceptional solutions to our clients. With a diverse range of backgrounds and skill sets, our team members embody our core values of creativity, integrity, and excellence. We foster an environment that encourages open communication, continuous learning, and a strong commitment to customer satisfaction.
Get to know the brilliant minds behind Triune Technologies and discover how our expertise can help drive your business forward. We are passionate about what we do, and we look forward to partnering with you on your next technological journey.
Welcome to our team!
Gabriel Opoku Adusei
MSc, PhD
Gabriel Opoku Adusei
MSc, PhD
Dr Gabriel Opoku Adusei has over 33 years of experience in the medtech and pharma industries interspersed with academic studies and professional career positions.
He has worked on many high-profile projects in the medical device technology industry in many different capacities influencing global regulatory practice with a number of articles he has authored and many meetings he has participated in as a keynote speaker.
His areas of expertise include Quality Management Systems and Regulatory Affairs covering Product Research, Design and Development, Risk Management, Usability and Human Factor Engineering, Biological Evaluation and Biocompatibility, Clinical Evaluation (including clinical investigations and trials), SaMD, Wearable and Connected Intelligent Health and Medical Devices, Information Security Management System and Data Protection among many others.
He was a Subject Matter Expert at BSI and Intertek (Notified Bodies) as Technical Reviewer and an Auditor where he gained extensive experience of auditing many companies worldwide.
He has a PhD in Biomaterials Science at King’s College, London and MSc in Pharmaceutical Science and Industrial Studies at University of Greenwich.
Ian Sealey graduated with a BEng (Hons) in Medical Engineering in 2003 and, after a taking a year out to study for a Graduate Diploma in Law, held health-related engineering and policy roles in the private sector, local government, and the National Health Service.
In 2012 he joined the Civil Service as a Medical Device Specialist at the Medicines and Healthcare products Regulatory Agency and, in 2015, was appointed assistant secretary at the Department of Health & Social Care, with responsibility for running its Departmental Board.
Since leaving the Civil Service in 2017 he has provided regulatory, quality, technical, and policy consultancy services to multinational and start-up medical device and in vitro diagnostic medical device manufacturers.
Ian Sealey
Ian Sealey
Joe Hagan-Brown
Joe Hagan-Brown
Joe is a QARA Consultant and the Director of MedRAS – a medical device consultancy firm, which he established in 2022. He has worked within the medical devices industry for over 10 years, in various roles and has a Batchelor of Science degree in Dental technology from the Manchester Metropolitan University.
After working in Dental technology post-graduation, Joe worked for the UK competent authority - MHRA between 2012-2019 as a Regulatory Affairs Manager; during which time, amongst other areas, he was responsible for leading the Joint Action on Market surveillance. He qualified as an ISO 13485:2016 lead auditor in 2013, and then went onto gain approval as an MHRA regulatory auditor.
Joe conducted MHRA audits of Notified Bodies and manufacturers, and was a member of the European Commission’s Joint assessment team- conducting MDR designation audits of EU notified Bodies during the early stages of the MDR implementation project.
In 2019, Joe left his role at the MHRA to take on a Notified Body auditor/ technical file reviewer role at Notified Body SGS (NB1639); gaining approval to audit under various regulatory / quality schemes including ISO 13485:2016, MDD, MDR, MDSAP and well as UKCA legal frameworks. Joe also managed a team of Notified body auditors during his time at SGS.
In September 2022, Joe left SGS to establish MedRAS Consultants Limited - established an independent limited company, providing consultancy, project management, training, and certification to people and organizations in the medical devices industry. Joe currently directs operations and delivers services to valued clients across the spectrum of the medical device industry in this role.
Karandeep Singh Badwal has experience in dealing with UKCA/CE Marking and FDA 510(k), conducting internal audits, hosting official audits from notified bodies, authoring of Technical Files/Design Dossiers and dealing with PMS activities including Field Safety Corrective Actions and Shipholds.
Experienced in working with Class I, II, III and Software-based AI Medical Devices to deliver results to time and quality targets, ensuring compliance with EU MDR 2017/745, UK MDR 2002 and US FDA requirements.
Karandeep Singh Badwal
Karandeep Singh Badwal
Ronald Boumans
Ronald Boumans
Ronald Boumans has a career working with medical devices that started in 1987 and covered almost all perspectives of improving safety and performance. He has worked in R&D, marketing & distribution, standard development, research into the quality of life in relation to medical devices, market surveillance for a competent authority, and high-end consulting for global companies.
Currently, he works for his own company, Boumans Regulatory Consulting, which is specializing in strategic regulatory consulting for manufacturers of medical devices or pharmaceutical companies involved in drug-device combinations, and PRRC services. His website is a source of free information for regulatory professionals that want to deep dive into European legislation.
Jenni Quaye is an experienced Quality Systems Specialist with a successful track record of developing and implementing effective quality assurance processes in a manufacturing, sales, service and corporate environment.
Jenni has effectively built and maintained a good rapport across the entire organisations and is a good communicator and well organised with excellent attention to detail. Jenni is an admirable and engaging team player who is an enthusiastic and highly self-motivated individual with a flexible but disciplined approach to work and takes great pride in achieving high standards.
Jenni has extensive experience in building, maintaining and supporting Legal Manufacturer site’s QMS system in accordance with ISO13485, FDA 21 CFR part 820 and EU MDR 2017/745 and is an SME and support for BSI ISO13485, MDSAP and internal audits. Jenni also performs internal audits and has completed the LRQA Lead Auditor course.
Jenni is experienced in representing Quality on project teams and has also been project lead on Quality projects.
Jenni has gained her experience with the QMS through working with small start ups, mid size and large multinational MedTech companies such as Hologic, Baxter Healthcare, and BD.
Jenni Quaye
Jenni Quaye
BScSathesh Kumar Annamalai
Sathesh Kumar Annamalai
Dr. Sathesh Kumar Annamalai is an accomplished Regulatory Affairs specialist with a Ph.D. in Bioengineering, focusing on in-vitro diagnostics and medical device regulations. With fourteen years of experience in R&D, and Key experience includes preparation and maintenance of technical files, product safety and vigilance reporting, clinical evaluations, risk assessment, regulatory audits, CE and notified body opinion submissions. Dr. Annamalai provides invaluable guidance to organizations seeking regulatory compliance. As a leader in regulatory compliance strategies, he has successfully guided organizations in meeting the EU Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) requirements.
With a pivotal role in drafting and editing high-risk clinical and regulatory documents, Dr. Annamalai excels in creating essential documents for regulatory filings and dossiers. His extensive experience spans clinical evaluation plans, reports, protocols, patient narratives, and compliance-related documents. Dr. Annamalai's excellent skills in writing and editing clinical development documents, including clinical protocols, investigator brochures, clinical study reports, subject consent forms, safety and efficacy summaries, presentation materials, and medical journal publications, ensure accuracy and compliance with regulatory standards.
Taking responsibility for preparing and coordinating regulatory submissions, reports, and correspondences, Dr. Annamalai collaborates closely with Quality, R&D, and management to develop regulatory strategies that expedite time to market and maximize product value. They also have extensive experience with biocompatibility evaluations of medical devices. Proactively identifying regulatory risks, Dr. Annamalai develops robust risk mitigation plans for company programs. He stay updated with regulatory trends, guidance, and anticipated changes to ensure effective alignment of regulatory policies, regulations, and standards. Additionally, Dr. Annamalai supports the vigilance team in meeting product dossier requirements and assists with post-marketing activities as needed. As an authorized representative, he meticulously reviewed and evaluated the technical and clinical documentation, ensuring compliance with relevant regulations.
Dr. Annamalai's unwavering dedication to maintaining regulatory compliance, deep understanding of regulations, and ability to streamline processes make them invaluable to any organization. They actively contribute to improving QMS processes and ensuring compliance with pre- and post-market product approval requirements during audits. Furthermore, Dr. Annamalai has authored over 45 international journal publications, showcasing their expertise and contribution to the field.
Following more than 20 years experience in senior Quality Assurance and Regulatory Affairs roles in a diverse range of Medical Device and In Vitro Diagnostic (IVD) companies. Richard has been delivering consulting solutions to a diverse range of clients for the last 10 years.
Having travelled the world honing his expertise and gaining an extensive range of industry contacts, Richard can offer a truly innovative range of services/solutions - all designed with you in mind. His goal is to provide you with exactly what you need, quickly and effectively covering Quality Assurance and Regulatory Affairs Globally with specific expertise in risk management, design, software, electromedical, class III implantables, companion diagnostics and borderline products.
Richard Young
Richard Young
Eric Berko-Mensah
Eric Berko-Mensah
Eric is an experienced practiced pharmacist in the Hospital, the Community and the Pharma Industry and possesses previous and current experience within virology (HIV), Endocrinology (diabetes) and Oncology.
Eric is an accomplished Clinical Research, Regulatory Affairs, Pharmacovigilance and Clinical Project lead with over 10 years of progressive experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring, study close-out visits and data management.
Eric is proficient in performing studies aligned with protocol, GCP/ICH E6 and E8 guidelines, FDA CFR 21, Part-C Division 5 of Health Canada, EMA, MHRA study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements, quality standards and submissions.
Eric is Detail-oriented self-starter and well-versed in managing projects, coordinating operations, managing sites and drafting detailed clinical reports according to Pharma industry standards, regulations and principles: QMS (ISO 13485, 90001, 14001), QA/QC, GDocP, cGDP, GVP, DMF, MDL/DEL, eCTD, NDSs, ANDSs, SNDSs, SANDSs, NCs, CTAs, HACCP, FSQR.
Duncan Light is a consultant surgeon in upper GI surgery in Northumbria NHS Trust. Duncan has experience in clinical surgery since 2005. He has experience in consulting on surgical technology and innovation. He has an interest in medical affairs and the process of bringing new devices to market. He has a Masters degree in medical education and extensive experience in performing clinical research.
His expertise, experience and skills include but not limited to:
Duncan Light
