Vestech Medical has a proven track record of successfully working with clients on design projects and achieving regulatory approval.
- Mechanical Design
- Product Risk Assessments
- Benchtop Testing
- Product User Testing
- Sourcing Manufacturers
- Design for Manufacture
- Technical File
Vestech can take your concept, and using its proven product development pathway design a product that meets your, as well as customer and regulatory requirements, leading to commercial success. Alternatively, we can partner with your product development team, and provide support where needed, such as running product risk assessment workshops or sourcing manufacturing vendors.
Regulatory approval depends not only on the product meeting performance and safety requirements but also regulators audit how the technical documentation was created. A medical device that is technically sound can still be denied regulatory approval if the design and development process did not follow ISO 13485 and/or 21 CFR 820. Vestech Medical can become your Legal Manufacturer, and thus develop the product within its certified ISO 13485 QMS, or provide mentoring services to ensure the development process is compliant to ISO 13485.
Whatever your needs, Vestech Medical has the expertise to provide support to your product development project and reduce the time to achieve regulatory approval and commercial success.