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.