My services in the field of Medical Devices:
- Support to CE certification / recertification of medical devices.
- Support to FDA 510 (k) clearance for US.
- Support for the creation of standard operating procedures (SOPs) for the quality management system.
- Support to compliance with IEC and ISO standards necessary for certification, both standards applicable to products and processes.
- Analysis of changes to certified products to examine if they are significant / substantial from the point of view of medical devices regulations.
- Support in revising the technical file due to significant changes for the EU and US.
- EU / US regulatory intelligence service on regulatory changes and new publications of IEC and ISO standards.
- Support in the gap analysis between the MDD and the MDR for EU and support for the compliance strategy to the MDR.
My specialties:
- Interpretation of the articles of law and applicable standards for the technology in question and support for the compliance strategy: MDD, MDR, 21CFR, ISO and IEC standards.
- Technical dossier review.
- Communication with the competent authorities: notified bodies, FDA, accredited laboratories.
- Compliance expert in D&D processes, risk management and usability.
- Test engineering for conformity to standards and management of Customer Test Facility according to IECEE and ISO 17025.
- Clinical Evaluation Report based on scientific literature and on performances.
- Drafting of standards in the IEC TC62 and TC45 standardization committees as Belgian expert (for radiotherapy, radiodiagnostics and dosimetry) and ISO TC210 (risk management, quality management system, usability).
- Lobbying in trade associations (COCIR, MITA)