Active Implants
Conceptualize, design, develop, industrialize and manufacture minimally invasive implantable devices.
Active Implant Design & Manufacture Capabilities
With the experience of more than 100 Class III implant projects, our team of experts can manage the design & development, manufacturing, supply chain, testing and quality requirements of the most challenging implant and implant accessory. With design teams in Switzerland, the USA and Romania we have the design resource to address your most complex implant to support yourr world wide development efforts.
We welcome you to bring us your most complex implant concept. We will use our expertise in miniaturization to help you with:
- Complete project managment model
- Design verification and product qualification
- Optimal design for manufacturability
- A miniaturized packaging solution offering yo an optimal size and reduced weight
- Final encapsulation, packaging and sterilization
- Reliability and performance that you and your customers can count on
Accelerating Time to Market
Typical Implant Project Sequences: 40 to 54 weeks with Design Review at each Stage
|
Phase One Feasibility |
Phase Two Design, Development & Assessment |
Phase Three Testing & Quaification |
Phase Four Manufacturing & Implementation |
|---|---|---|---|
| Concept / Project Approval | Marketing Acceptance | Engineering Production Documentation | Production Documentation/ Device Master Record |
| Project Team | Design, Development Documentation | Update Risk Mgt Plan | Acceptance for Mfg. |
| User Needs | Risk Mgt Plan | Process FMEA Validation | Risk Mgt. File |
| Risk Management (Mgt) Plan | Design FMEA | Results Design Validation | Final Design Review |
| Design Inputs | Design Freeze | Clinical Plan Update or Implementation | |
| Design Plan | Quaity Plan | Risk Mgt. Report | |
| Project Timeline | Validation Master Plan | Manufacturing Implementation | |
| Marketing Strategy | Design Testing Plan | Document Reviews | |
| Quality Strategy | Forecast Logistics Plan | Design Review | |
| Regulatory Strategy | Environmental, Health & Safety Review | ||
| Manufacturing Strategy | Manufacturing Strategy | ||
| Intellectual Property | Requirements Check List | ||
| Design Testing Results | |||
| Design Verification/ Document Reviews | |||
| Design Review |
