Medical Device and In-Vitro Diagnostics

Towards predictive and individualised medicine

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

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
  • Verification work for a new blood typing IVD solutions
  • V&V management for a Wi-Fi eHealth platform connecting medical devices to the cloud
  • Hardware sustaining project for an infusion pump

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 a portfolio of injection products
  • Pre-market notification 510(k) for a reusable mechanical pen-injector

Interventions

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

References and technical expertise

  • Contract writing, negotiation and IP respect for Medical devices
  • Continuous improvement for a QC laboratory
  • 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 aseptic 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 expertise

  • Project management for the re-design of peristatic pumps
  • Design a new stent manufacturing facility
  • Project Manager for redesign of combination products (R&D, RA, QA)
  • R&D Risk management (ISO 14971)