agap2 intervenes on Medical technology & Diagnostics projects, from series development to technical documentation and support in the implementation of new regulations.
Discover our areas of expertise.
Medical devices and medical equipment
- Development of medical devices (according to MPG, DIN EN ISO 13485 and FDA 21
- CFR Part 820
- Software development for medical devices
- Regulatory Affairs/ Approval
- Change Management
- Development/optimisation of in vitro diagnostics
- Documentation support
- Quality Management
Product development
- Feasibility studies
- Preparation of specifications and requirements
- FEM simulation calculation
- Embedded software development
- Human Factor Engineering
- Design of electromechanical assemblies
- Technical and economic component selection
- Prototype qualification
- Technical project management
Production
- Process transfer
- Series ramp-up Production support
- Qualification (production facilities, clean rooms)
- Validation (processes, cleaning, transport)
- Validation of computerised systems (CSV)
- Process optimisation Continuous improvement process (Lean Manufacturing, Six Sigma, 5 S, Kaizen)
- Contract management with Contract Manufacturing Organisations (CMOs)
- Project management
Quality management
- Quality control (method development and validation)
- Quality assurance (GMP, GCP)
- Support of quality systems (deviation, change, document management, complaint management, training, supplier qualification)
- Inspection preparation (mock audits) and support during inspections by the authorities
- Regulatory affairs (coordination and implementation of approvals, publishing)
Project management
Different levels of commitment.
Commitment to results.
Commitment to results is adapted to services for which the client wants agap2 to commit to fixed objectives. It is intended for projects defined in the specifications, for which agap2 proposes a cost calculation per task or project milestone. It allows the search for optimisation and productivity gains and is distinguished by invoicing by deliverables (tasks or milestones).
Resource commitment.
Resource commitment 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 the invoicing of the time spent on the project.
Discover our intervention methods.
Our interventions aim to respond to our clients’ problems in the most accurate and appropriate way possible.
- Temporary employment : Counselling on the current AÜ law | Flexible integration and easy adaptation of the activity | Operational support of the project manager | Invoicing of the hours worked according to the hourly rate
- Service and consulting contract : Consultation in the elaboration of the project definition | Independent implementation of the projects on site | Project documentation | Communication and project support | Invoicing of the hours worked according to the hourly rate
- Contract for work : Detailed clarification of the assignment, stocktaking and preparation of the project concept | Project structuring with solution-oriented milestones | Communication and project support | Invoicing of the total order according with optional instalment payments according to the status of service provision