agap2 will advise you on the development and production of medical devices.
All our areas of expertise.
Engineering and R&D
- HW and SW development
- Mechanical & Electronics
- Human Factor Use Ability
- Quality Assurance
- Quality Control
- Deviations, anomalies, nonconformities
- Setting up and CAPA follow-up
- Chance control management
- MDR Compliance, Writing and updating technical file (510K/CE Marking)
- Specific regulatory requests
Registration and renewal of MD
- Regulation 2017/745 & Directive 93/42/CEE
- Version management for the ISO 13485 Standard
Industrialization, Qualification and Validation
- Manufacturing support
- Equipment qualification and Process validation
- Validation of computerized systems (GAMP5, 21CFR part11)
- Risk management and budget planning
- Lean management
- Methods maintenance
- Supply chain management
1 - Specification, design, V&V, CE Marking of a new spine implant for SpineArt in Geneva.
Specification, design, V&V, CE Marking of a new spine implant and associated surgery instruments using SolidWorks.
2 - Support of corrosion test lab for J&J Depuy Synthes in Oberdorf.
Support of corrosion test lab and managing test requests.
Study direction for writing of clinical reprocessing test reports based on completed corrosion resistance test results.
3 - Medical ventilator certification in aviation for Aerolite AG in Ennetbürgen.
Develop and maintain technical documentation of a medical ventilator regarding all regulations (MDR, ISO 13485, 93/42/EWG) and accompany the process from development up to submissions of the devices.
4 - Process manufacturing transfer and process duplicate from USA to Switzerland for Cytiva .
Suppliers coordination and follow up from equipment design to site installation.
Creation and writing of all documents related to Qualification/Validation.
A dedicated solution for every single project.
We recommend the collaboration model best suited to your specific needs. Drawing on 10 years of experience in engineering services, we’ve developed two collaboration models.
Technical assistance: we provide resources to support your assignments, ensuring tremendous agility and rapid responsiveness, especially for projects whose scope can frequently change.
Commitment to performance: we work on site for projects lasting over three months whereby specific goals are defined.