David Houot

David Houot currently serves as the General Director and Senior Consultant at ExpeReg, where he leverages over 16 years of extensive experience in the Medical Devices industry to drive strategic growth and operational excellence. In his leadership role, David is responsible for developing and implementing high-quality business strategies and plans that align with both short-term objectives and long-term vision. His deep expertise in regulatory affairs, quality management systems, and compliance ensures that ExpeReg’s clients navigate complex regulatory landscapes with confidence, particularly in areas such as ISO 13485, CE marking, and sterilization processes.

At ExpeReg, David plays a pivotal role in overseeing all operational activities, ensuring that service delivery consistently meets the highest standards of quality and regulatory compliance. His background as a qualified Lead Auditor with Notified Bodies (CE+ISO) enables him to provide invaluable guidance on auditing procedures, technical documentation, and microbiology and biocompatibility assessments. He has successfully supported numerous medical device manufacturers in preparing comprehensive Technical Files, optimizing sterilization validation, and implementing robust quality systems.

David’s expertise extends to training and mentoring teams on regulatory requirements, risk management, and compliance strategies, helping clients achieve and maintain certifications essential for market access. His strategic insight and hands-on experience make him a trusted partner for companies seeking to streamline their regulatory pathways, enhance product safety, and ensure compliance with evolving industry standards. Through his leadership, ExpeReg continues to strengthen its reputation as a leading consultancy in the medical device sector, dedicated to fostering innovation while maintaining rigorous regulatory adherence.