About Us

Leadership

MedTec Consulting is led by Dawn Smiles, a regulatory and commercial specialist with experience across medical devices, diagnostics and digital health technologies. We operate as a focused, senior consultancy – working closely with innovators to design structured, proportionate and scalable regulatory systems.

Dawn Smiles CSci FIBMS

Founder & Clinical Director

Dawn leads MedTec Consulting with a specialist focus on regulatory strategy, Technical Documentation development and quality management systems for medical devices, SaMD and AI-enabled technologies.

She holds Chartered Scientist (CSci) status with the Science Council and is a Fellow of the Institute of Biomedical Science. With a clinical foundation in Biomedical Science and Medical Microbiology, Dawn brings an evidence-driven approach to regulatory architecture, risk management and patient safety.

Her expertise includes UKCA and CE marking, ISO 13485 implementation, clinical and performance evaluation, post-market strategy and integrated QMS development. She holds externally examined practitioner credentials from BSI across lead auditing, MDR/IVDR frameworks and AI management systems.

Dawn works closely with innovators and SMEs to translate complex legislation into clear, proportionate and implementable regulatory systems.

David Smiles

Managing Director

David brings an engineering-led perspective to MedTec Consulting’s regulatory and technical programmes.

Holding an honours degree in Professional Engineering, he advises on technical design considerations, system architecture and practical implementation challenges within medical device development. His background in safety management, supported by IOSH and NEBOSH certification, strengthens our approach to risk evaluation and operational compliance.

With almost two decades of experience managing complex, high-value projects, David ensures that regulatory planning is grounded in technical feasibility, structured execution and disciplined delivery.

Pankaj Chaddah

General Manager

Our General Manager Pankaj has over 30 years experience in the healthcare industry and holds honours degrees in both Medicinal and Pharmaceutical Chemistry, and Biological Sciences.

With a biomedical researcher background, prior to several decades in medical and pharmaceutical sales and training, his networks within multi-disciplinary clinical teams reflect a unique understanding of the vision and challenges of the continually-changing NHS environment.

Lorna Middleton MSc CSci FIBMS

Advisory Consultant: IVD & Laboratory Systems

Lorna brings over 20 years of experience in laboratory medicine, with specialist expertise across microbiology, virology, blood transfusion and clinical biochemistry.

A Chartered Scientist with an MSc in Virology, she provides advisory input on in vitro diagnostics (IVDs), laboratory workflows and quality management systems. Her practical experience within accredited laboratory environments informs our approach to IVD Technical Documentation, performance evaluation and post-market considerations.

Lorna also acts as an assessor for the Institute of Biomedical Science (IBMS), strengthening our understanding of laboratory governance and professional standards.

Gina Hogg

Finance & Operations

Gina oversees financial management and operational administration at MedTec Consulting, ensuring client engagements are supported by structured, transparent and efficient processes.

Holding a Master’s degree in Chemistry and bringing experience from the pharmaceutical and healthcare sectors, she applies analytical rigour and attention to detail to accounts, invoicing and internal operations.

Her role underpins the smooth delivery of client programmes – maintaining financial clarity and organisational discipline across the consultancy.