Medical Device

What can we do to detect illness before the person actually becomes ill? That is medicine’s challenge for the future.

Towards predictive and individualised medicine.

agap2 medical device expertise

  • Our agap2 team is segmented into 5 groups. Each group contributs with its knowledge and expertise to every project development stage from inception to completion. Our consultants speak english, german and french.

Areas of expertise

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