Successful medical devices must not only provide a convincing technical solution. Relevant regulatory requirements, standards, safety and performance requirements need to be considered from the very beginning of product development.
My extensive experience combines a strong technical understanding of medical devices with regulatory expertise. The focus is on the practical integration of product development, standards compliance, risk management, usability, documentation and regulatory strategy.
Regulatory requirements should inform development decisions at an early stage so that potential hurdles can be identified before they cause delays in development or regulatory approval.
Extensive experience includes the assessment and implementation of applicable standards and regulatory product requirements, the establishment and execution of risk management processes, and usability evaluations. The objective is to create well-founded technical decisions and consistent development documentation.
Experience includes development and regulatory documentation as well as the analysis of regulatory issues. A particular area of experience is the analysis and resolution of regulatory deficiencies, including robust responses and appropriate measures aligned with technical and regulatory requirements.
Extensive experience in dealing with audits, questions from regulatory authorities and complex regulatory issues, including the assessment of technical and organizational matters and the development and presentation of appropriate solutions.
Experience with regulatory requirements and approval processes in different international markets, with particular knowledge of the European Medical Device Regulation (MDR) and requirements of the U.S. Food and Drug Administration (FDA). Additional experience includes regulatory pathways in Japan and India.
Robust regulatory documentation must clearly and traceably demonstrate the development of a medical device and its compliance with applicable requirements. Combining detailed product knowledge with sound regulatory reasoning is often essential for addressing the underlying questions effectively.
Regulatory requirements for different markets should not be considered in isolation. The objective is to identify at an early stage how different requirements may affect product development, verification, documentation and regulatory strategy.
Many regulatory requirements influence fundamental decisions concerning product concept, technical design, risk management, verification, usability and manufacturing. My experience in product development, project management and international regulatory processes enables me to identify these interdependencies at an early stage and translate regulatory requirements into technically sound and commercially viable development strategies. In this way, Regulatory Affairs becomes not an obstacle to innovation, but an integral part of successful medical device development.
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