Contract Manufacturing Services

Mediologix Biopharma offers a full suite of contract manufacturing services for medical devices. Our modular service model allows you to engage with us at any stage—from early design to full commercialization.

3.1. Product Development & Design
  • User-centric device engineering
  • Design for Manufacturability (DFM) optimization
  • Rapid prototyping (3D printing, CNC, silicone molding)
  • Risk and failure mode analysis (FMEA)
  • Pre-verification feasibility testing
3.2. Manufacturing & Assembly
  • Cleanroom manufacturing (ISO Class 7 & 8)
  • Manual and semi-automated assembly lines
  • Combination product integration (drug-device)
  • Injection molding, ultrasonic welding, adhesives
  • Device testing and batch verification
3.3. Sterile Packaging & Logistics
  • Final device packaging (blister, tray, pouch, etc.)
  • Sterilization coordination: gamma, EtO, E-beam
  • Labeling & barcoding per FDA and EU standards
  • Cold chain logistics for temperature-sensitive devices
  • Kitting & distribution-ready assembly
3.4. Quality & Regulatory Services
  • ISO 13485:2016 quality management system
  • Documentation & traceability systems
  • FDA submission support (510(k), PMA, Q-Subs)
  • CE Mark and MDR technical files
  • Post-market surveillance and complaint handling
3.5. Supply Chain Management
  • Component sourcing from approved vendors
  • Vendor audits and supplier qualification
  • Inventory planning & lot control
  • Materials management for GMP compliance
  • Risk-managed procurement solutions
3.6. Lifecycle & Aftermarket Services
  • Device updates & modifications
  • Rework and reprocessing programs
  • Customer feedback analysis
  • Sustaining engineering support
  • End-of-life planning and replacement strategies