Medical Devices

agap2 Life Sciences is involved in the entire life cycle of a healthcare product: drugs, medical devices, biotechnologies.

Our expertises

Discover our areas of expertise.

Engineering and R&D

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

Quality & Regulatory affairs

  • Quality assurance
  • Quality control
  • Regulatory affairs – Regulatory monitoring
  • Quality management
  • Logistics management / Industrial transport

Qualification & Validation

  • Site work supervision, On-site installation
  • Equipment qualification (process, utilities)
  • Process validation (manufacturing, cleaning, sterilization)

Project Management

  • 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
Our offer

Different levels of commitment.

  • Commitment to results.

The commitment to results is adapted to services for which the client wishes agap2 to commit to achieving fixed objectives. It is intended for projects defined in the specifications, for which agap2 proposes a costing per task or project milestone. It allows the search for optimisation and productivity gains and is distinguished by invoicing by deliverables (tasks or milestones).

  • Commitment of resources.

The commitment of resources is the most common. It allows great flexibility and responsiveness. It is mainly intended for projects without specifications, with a scope that can change regularly. It is characterised by invoicing for time spent on the project.

Discover our intervention methods.

The aim of our interventions is to respond to our clients’ problems in the most accurate and appropriate way possible. To do this, we have built our offer on 4 modes of intervention with increasing levels of commitment.

  • Consulting activity: Individual resource management | Contract for each consultant | Responsiveness and flexibility | Commitment of means
  • Defined projects: Projects based on defined specifications | Project management by Projects Solutions | Implementation of a multidisciplinary team | Commitment to results
  • Technical platform: Centralised activity | Delegation of management Single contract | Management of skills and resources by Projects Solutions | Commitment of means
  • Outsourcing: Management of recurrent activities | Division of activities into tasks or work packages | Management of the workload by Solutions Projects | Commitment to results

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