Our support throughout the life cycles of your MDs

Our offerings

stage1 :PRELIMINARY STUDIES

  • Functional analysis / Pre-study (market analysis, patent analysis, etc.)
  • Drafting of specifications
  • Proposal of technical, regulatory and normative solutions
  • Risk analysis (AMDEC 60601-1, 60601-1-8, 60601-2-24, etc.)

stage2 :DESIGN AND SIZING

Mechanics / Biomechanics & plastics

  • Design
  • Product development
  • Trials and validation

Electronics & computing IEC 62304

  • Software V-model (specification, design, development and validation)
  • Electronic system V-model (specification, design, development and validation)

stage3 :VERIFICATION & VALIDATION

  • Drafting of medical device verification protocols
  • Performance of V&V tests

stage4 :INDUSTRIALISATION OF MDs

  • Production line design: Project planning, Preliminary Workflow, Design review, AMDEC Process, online Architecture, Specifications, Packaging & traceability of each component.
  • Production: Drafting of specifications regarding equipment and the maintenance thereof, as well as production instructions. Creation of production monitoring indicators.
  • Validation: Validation of line equipment.
Contact one of our specialists
a few facts and figures
71 CE RENEWALS ISSUED
21 INITIAL CE MARKINGS OBTAINED
115 CERTIFICATION/VALIDATION OF EQUIPMENT
news MEDICAL DEVICES