Thomas Miramond has 14 years of experience in the medical device industry, with a strong focus in the orthopaedic and dental fields. His previous experiences range across several different spectrums of the industry—from his work with collaborative translational health research projects, roles as an R&D project manager and expert-assessor for both EU Medical Device Directive (MDD) and EU Medical Device Regulation (MDR) devices and providing consultations on the valorization of research and innovation.

CORE COMPETENCIES

• Orthopaedic and dental devices, with a core focus on implantable devices including state-of-the-art standards for preclinical characterization methods (ASTM, ISO) and biocompatibility (ISO 10993 series, GLPs)
• Reviewing implantable Class IIb and III applications to MDR, including reviewing summary of safety and clinical performances (SSCPs) and periodic safety update reports (PSURs) in line with the Medical Device Coordination Group (MDCG) guidance, as well as drafting clinical evaluation assessment reports (CEARs)
• Developing regulatory strategy for bringing new devices to market (U.S., EU)
• Performing gap analyses of regulatory and clinical strategies, submissions and key documents to MDD and MDR
• Developing orthopaedic and dental devices from concept to launch on EU and U.S. markets, including developing strategies for design development, scale up, design and manufacturing validation, stability studies and biocompatibility under Good Laboratory Practice (GLP)
• Advanced Therapeutic Medicinal Product (Stem cells and scaffolds)
• Preparing design dossiers and technical files according to MDR and Notified Body requirements
• Medical devices utilizing animal tissue
  • Providing strategic advice
  • Preparing submissions in compliance with EN22442 parts 1-3 and Regulation 772/2012
  • Assembling key documents, including comprehensive documented justification of the use of the animal material
  • Composing expert reports for Transmissible Spongiform Encephalopathies (TSE) monograph
  • Assistance with European Directorate for the Quality of Medicines & HealthCare (EDQM) submissions
• Interpreting and implementing MDCG guidance documents
• Regulatory due diligence in relation to mergers, acquisitions and investment projects
• Consortium set-up for EU grants (H2020 framework) and Research Tax Credit scientific files to support Ministry of Research and Innovation expert audits
• Conducting training on CE marking requirements, including developing training materials and presentations

RECENT PROJECTS

• Developed an MRO program for a complete accompaniment from R&D to market access through 510(k) and CE marking (MDR), including strategic summary for orthopaedic and dental indications, ISO 13485 design control gap assessment, ISO 14971 Failure Mode and Effects Analysis (FMEA) gap assessment, Technical Documentation audit, state-of-the-art writing, benchmarking for equivalency according to MDCG 2020-5, valorization of innovation and R&D project management support and MDR training
• Labels and instructions for use (IFUs) gap assessment review