Venture Studio for Mechanical Engineering: Development, Regulatory, and Industrialization of Medical Devices
Fainova Venture Studio Sagl
Chiasso (CH) · Turin (IT)New on Amplifa
About Fainova
Fainova Venture Studio Sagl is a service and venture studio company founded in 2018 for medical technology, pharmaceuticals, and life sciences. The company develops MedTech Ventures based on scientifically verified technologies, examining clinical need, market, scientific evidence, and technologies before establishing its own ventures. The service platform includes design and engineering, regulatory support, ISO 13485-related activities, and the industrialization of medical devices. Furthermore, Fainova develops instruments, methods, and data that support scientific measurements in clinical applications. The ventures are guided through staged validation and supported until their spin-off as independent companies. Fainova is active with locations in Chiasso (Switzerland) and Turin (Italy) and is led by founder Franco Fae.
- Site
- Chiasso
- Processes
- Design and Engineering (MedTech), Regulatory support (ISO 13485), Industrialization for Medical Devices, Test and Measurement, Design & Engineering for MedTech/Pharma, Regulatory Support, ISO 13485-related Activities, Industrialization of Medical Devices
- Materials
- Regulatory Support (ISO 13485), Design & Engineering, Test and Measurement
- Certificates
- ISO 13485 (Regulatory Support)
- Founded
- 2018
- Employees
- 1-10
- Industries
- Medical Technology (MedTech), Pharma, Healthcare, Life Sciences
- 01
Clinical Need and Market Assessment
- 02
Design & Engineering
- 03
Regulatory Support (ISO 13485)
- 04
Industrialization
- 05
Staged Validation and Venture Operations
Services and Competencies
Regulatory Support (ISO 13485)
Support for MedTech and pharmaceutical companies with ISO 13485-related activities.
Design & Engineering
Development and industrialization of medical devices from the concept phase to serial readiness.
Test and Measurement
Development of instruments, methods, and data to support scientific measurement in clinical applications.
Locations
Chiasso
CHLocation
Turin
ITLocation
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Design and Engineering (MedTech)Engineering | – | – | – | – | – |
| Regulatory support (ISO 13485)Engineering | – | – | – | – | – |
| Industrialization for Medical DevicesEngineering | – | – | – | – | – |
| Test and MeasurementTesting | – | – | – | – | – |
Additional services
Quality and Regulatory
Fainova offers Regulatory Support focusing on ISO 13485-related activities for medical devices; information on proprietary certificates is not available.
| Evidence | Chiasso | Turin |
|---|---|---|
| ISO 13485 (Regulatory Support) |
History
- 2018
Founded in December 2018 as an industrial service company for MedTech and Pharma (Design & Engineering, Regulatory) by Franco Fae.