Fabienne Mathies

Medical device manufacturers often face compliance delays, a lack of specialized internal resources, or the growing complexity of international regulations. My role as a QARA consultant is to provide both operational and strategic support to secure regulatory compliance and accelerate market access.

With over 20 years of experience in quality assurance and regulatory affairs within the medical device industry, I support clients across the entire product lifecycle:

• Compliance with Regulation (EU) 2017/745 (MDR), Directive 93/42/EEC (MDD), and standards such as ISO 13485 / ISO 9001.
• Implementation and improvement of Quality Management Systems (QMS).
• Preparation and update of technical documentation and regulatory submission files.
• Coordination of audits (Notified Bodies, FDA) and risk management.

My methodology is based on:

• Tailored advice, adapted to each client’s regulatory maturity and priorities.
• High responsiveness, ensuring timely support for audits, inspections, or submissions.
• Knowledge transfer and best practices, empowering internal teams to maintain long-term compliance.

• Document-based quality and regulatory compliance audits (via SharePoint, digital QMS tools).
• Review of technical documentation and follow-up on corrective actions.
• Project steering and progress meetings via videoconference (Microsoft Teams, Zoom).
• Remote support for the implementation or improvement of QMS.
• Supervision and validation of international regulatory submissions.

• Achievement and maintenance of CE marking in compliance with the MDR.
• Significant reduction of non-conformities during audits and inspections.
• Time savings in the preparation and approval cycles for regulatory submissions.
• Secured and accelerated access to international markets (EMEA, United States, Canada, Asia, South America).