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