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