We have extensive Product Development experience with both Multinational and Start-up Medical Device companies. We have developed quality management systems that meet both International and Regulatory requirements. We will develop and implement a Product Realization Process that meets your specific requirement. We have extensive experience in:
- Regulatory Design Requirements,
- Product Realization Process,
- Design Verification,
- Design Validation,
- Risk Management,
- Product Specification Development,
- Design Reviews,
- Test Method Qualification,
- Product Performance Qualification and
- Process Performance Qualification.
We have extensive experience in Design for Six Sigma methodologies to ensure the product functions meet the needs of the Customer and that the chosen technology will perform those functions in a robust manner throughout the products life. DFSS Tools include:
- Concept Develop Optimise Validate (CDOV) Roadmap,
- Voice of Customer
- Kano Analysis,
- Pugh Concept,
- Critical Parameter Management,
- Robust Design,
- Design of Experiments (DOE) and
- Advanced Statistical Tools.
We offer Product Development and DFSS expertise to start-up and existing Medical Device Companies engaged in the design and manufacture of medical devices.