Thomas Miramond, ex-BSI Scheme Manager and Technical Specialist, has 15 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.

With extensive expertise in medical device regulations and Notified Body experience, Thomas has served as a Technical File and Design Dossier auditor at a leading EU Notified body (BSI 2797), specializing in MDD and MDR. Their focus on orthopedic and dental devices, especially implantable, includes proficiency in preclinical methods and biocompatibility standards. With over 50 technical documentation reviews and a key role in maintaining BSI client certification, they contributed significantly to regulatory compliance and quality in the industry, complemented by involvement in training BSI auditors on bioceramics devices.

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
• MDR PMCF Strategy and PMCF Plans issuance
• Clinical Evaluation Plan and Report review
• MDR full technical documentation gap assessments
• Implant cards, labels and instructions for use (IFUs) gap assessment review
• MDR QMS procedures drafting
• Notified Bodies non-conformities remediation

PUBLICATIONS

• Daculsi, Guy; Fellah, Borhane; Miramond, Thomas; Durand, Marlène (2013) Osteoconduction, Osteogenicity, Osteoinduction, what are the fundamental properties for a smart bone substitutes. In : IRBM, vol. 34, n° 4-5, p. 346–348. DOI: 10.1016/j.irbm.2013.07.001.
• Daculsi, Guy; Miramond, Thomas; Borget, Pascal; Baroth, Serge (2012) Smart Calcium Phosphate Bioceramic Scaffold for Bone Tissue Engineering. In : Key Engineering Materials, 529-530, p. 19–23. DOI: 10.4028/www.scientific.net/KEM.529-530.19. D
• Daculsi, Guy; Miramond, Thomas; Borget, Pascal; Morineau, Claire; Elodie, Seris (2015) Clinical Performance of Moldable Bioceramics for Bone Regeneration in Maxillofacial Surgery. In : Journal of Biomimetics, Biomaterials and Biomedical Engineering, vol. 25, p. 69–72. DOI: 10.4028/www.scientific.net/JBBBE.25.69.
• Miramond, Thomas; Aguado, E.; Goyenvalle, E.; Borget, Pascal; Baroth, Serge; Daculsi, G. (2012) In Vivo Comparative Study of Two Injectable/Moldable Calcium Phosphate Bioceramics. In : Key Engineering Materials, 529-530, p. 291–295. DOI: 10.4028/www.scientific.net/KEM.529-530.291.
• Miramond, Thomas; Aguado, Eric; Goyenvalle, Eric; Moreau, Françoise; Borget, Pascal; Daculsi, Guy (2013) Osteopromotion of Biphasic Calcium Phosphate granules in critical size defects after osteonecrosis induced by focal heating insults. In : IRBM, vol. 34, n° 4-5, p. 337–341. DOI: 10.1016/j.irbm.2013.07.004.
• Miramond, Thomas; Borget, Pascal; Baroth, Serge; Daculsi, Guy (2013) Comparative Critical Study of Commercial Calcium Phosphate Bone Substitutes in Terms of Physico-Chemical Properties. In : Key Engineering Materials, vol. 587, p. 63–68. DOI: 10.4028/www.scientific.net/KEM.587.63.
• Miramond, Thomas; Borget, Pascal; Colombeix, Caroline; Baroth, Serge; Daculsi, Guy (2012) Composite Bioceramics/Polymer Electrospun Scaffolds for Regenerative Medicine. In : Key Engineering Materials, 529-530, p. 441–446. DOI: 10.4028/www.scientific.net/KEM.529-530.441.
• Miramond, Thomas; Borget, Pascal; Moreau, Françoise; Fellah, Borhane; Daculsi, G. (2016) Hollow Shells Development and Characterization for Cells Carrying Purpose. In : Key Engineering Materials, vol. 696, p. 238–242. DOI: 10.4028/www.scientific.net/KEM.696.238.
• Miramond, Thomas; Corre, Pierre; Borget, Pascal; Moreau, Françoise; Guicheux, Jérôme; Daculsi, Guy; Weiss, Pierre (2014) Osteoinduction of biphasic calcium phosphate scaffolds in a nude mouse model. In : Journal of biomaterials applications, vol. 29, n° 4, p. 595–604. DOI: 10.1177/0885328214537859.
• Miramond, Thomas; Galtier, Thibaut; Daculsi, Guy; Borget, Pascal (2014) Calcium Phosphate-Loaded Strips, Plugs and Putties. Physico-Chemical Properties for Osteopromotion and Ease of Surgery. In : Key Engineering Materials, vol. 631, p. 83–87. DOI: 10.4028/www.scientific.net/KEM.631.83.
• Miramond, Thomas; Rouillon, Thierry; Daculsi, Guy (2014) Biphasic Calcium Phosphate. Preferential Ionic Substitutions and Crystallographic Relationships at Grain Boundaries. In : Key Engineering Materials, vol. 631, p. 73–77. DOI: 10.4028/www.scientific.net/KEM.631.73.
• Plank, Christian; Eglin, David; Fahy, Niamh; Sapet, Cedric; Borget, Pascal; van Osch, Gerjo et al. (2012) Gene activated matrices for bone and cartilage regeneration in arthritis. In : European Journal of Nanomedicine, vol. 4, n° 1. DOI: 10.1515/ejnm-2012-0001.
• Daculsi, Guy; Aguado, Eric; Miramond, Thomas Essential Requirements for Resorbable Bioceramic Development: Research,Manufacturing, and Preclinical Studies, p. 471–501.
• Daculsi, Guy; Fellah, Borhane Hakim; Miramond, Thomas (2014) The Essential Role of Calcium Phosphate Bioceramics in Bone Regeneration. In : Besim Ben-Nissan, coord.: Advances in Calcium Phosphate Biomaterials, 2etome. Berlin, Heidelberg: Springer Berlin Heidelberg (Springer Series in Biomaterials Science and Engineering), p. 71–96.
• Daculsi, Guy; Miramond, Thomas (2013) Calcium Phosphate–Derived Biomaterials. In : G. C. K. Roberts, coord.: Encyclopedia of biophysics. First edition. Berlin: Springer (Springer reference), p. 206–211.
• Miramond, Thomas (2012) Développement de matrices céramiques et composites pour l’ingénierie tissulaire osseuse. Université de Nantes (Ph.D. thesis).