Requirements & Specifications
Support to write requirements and specifications. Establish traceability. A strong ground is mandatory to launch a development.
Activity covers common specifications, applicable standards, intended use, usability, predicates analysis, complaint database, key opinion leaders interview, field interviews, marketing inputs, process inputs, design and development inputs, etc
Product and Process Design & Development
Content to come
Project, Product and Process Risk Analysis
Content to come
Verification & Validation
Content to come
Manufacturing
Content to come
Project & Program Management
Content to come
Start-up Consulting
Content to come
We developed about 20 medical devices, a good part of them being active implants (class III).
Kind of devices in alphabetical order:
- Apnea implants
- Artificial sphincters
- Blood processing equipments
- Catheters
- Cochlear implants
- Coolers
- Deep Brain Stimulators
- EEG monitoring implants
- Endoscopes
- Eye implants
- Gastric pills
- Glucose monitors
- Gynaecological devices
- Surgical robots
Our key competences are:
- Run a project from feasibility to industrialization
- Establish manufacturing processes
- Select and setup collaboration with suppliers, subcontractors and co-developers
- Well aware of the Regulatory environment and required Quality Management
- Break walls to solve problems