Dispositifs Médicaux

Comment faire pour détecter les maladies avants qu'elles ne se déclarent ? C'est le défi de la médecine de demain.

Vers une médecine prédictive et individualisée.

L'expertise agap2 dans les Dispositifs Médicaux

  • Notre équipe agap2 est segmentée en 5 groupes. Ils interviennent à différents niveaux avec leurs connaissances et leur expertise sur toutes les phases d'un projet de la conception à la réalisation . Nos consultants parlent anglais, allemand et français.

Pôles de compétences

interventions

Product – R&D

  • HW Development, SW Development
  • Mechanical engineering – Material science
  • Human factor engineering
  • System Integration, Verification & Validation (HW/SW)

Process – Engineering

  • Mechanical, Electrical, Automation, Process
  • Manufacturing, technical transfer

References and technical expertise

  • Human factors studies on combination products (ISO 62366)
  • Process expertise for packaging production lines (ISO 11607)
  • Design, implementation of an automated production line (ISO 13485)
  • SW (software, firmware) development on blood screening devices
  • HW (Injection, design, FEA) development on blood screening devices

Interventions

  • Quality assurance
  • Quality control
  • Regulatory affairs – Regulatory monitoring
  • Quality management
  • Logistics management / Industrial transport

References and technical expertise

  • SW Quality Assurance implementation (Agile SCRUM, V&V)
  • QA remediation work on suppliers (ISO 13485, 21 CFR 820)
  • QC method development, validation and transfer (micro-crack detection in plastics injections devices)
  • Support on Quality Systems Regulations (doc and maintenance work)
  • Worldwide registration of an injection products portfolio (Regulatory affairs)

Interventions

  • Purchasing, Category Management
  • Lean Management, Continuous Improvement
  • Logistics
  • Expediting

References and technical expertise

  • Contract writing, negociation and IP respect for Medical devices
  • Continuous improvement for QC labs
  • Purchasing and Contract Management (CDAs, Service Agreement…)
  • 5S implementation and Lean management for a vaccines warehouse

Interventions

  • Site work supervision, On-site installation
  • Equipment qualification (process, utilities)
  • Process validation (manufacturing, cleaning, sterilization)

References and technical expertise

  • Process validation for an inhaler production line
  • Installation management for 2 production lines (FAT/SAT IQ-OQ-PQ) with alcohol sterilization process (ATEX)
  • Qualification of lenses production line (DQ-FAT-SAT-IQ-OQ)
  • Validation of asceptic filling line (Process, CSV, QC lab equipment)

Interventions

  • Product/Project/Program Manager (PMI or IPMA certified if needed)
  • Project Management Office: Cost control/Planning/Risk
  • Management
  • Technical Project Manager
  • Project Quality Management (global, QA, QC)
  • Life Cycle Management

References and technical exptertise

  • Project management for re-design of peristatic pumps
  • Design and financial planning for new clean rooms implementation
  • Project Manager for redesign of combination products (R&D, RA, QA)
  • R&D Risk management (ISO 14971)
  • PMO (Project controlling, Scheduling, Risk Management) for an international innovative vaccine launch