Product Development

Product Development

Vestech Medical has a proven track record of successfully working with clients on design projects and achieving regulatory approval.

Services include:

  • Mechanical Design
  • Prototyping
  • 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.

One of our successful design projects involved a client who had a concept for a new medical device but had limited experience with product development and regulatory approval processes. The client approached us for assistance, and we worked closely with them to understand their requirements and ensure compliance with regulatory standards. 

We began the project by conducting a product risk assessment to identify and mitigate potential hazards associated with the device. Once the risks were identified and mitigated, our team designed the components of the device and created prototypes for testing. The prototypes were subjected to benchtop testing and user testing to ensure that the device met both regulatory and customer requirements. 

After finalising the design, we assisted the client in sourcing manufacturers and designing for manufacture. Our regulatory team also created the technical file required for regulatory approval, ensuring that the development process followed ISO 13485 and 21 CFR 820 requirements. 

Thanks to Vestech’s expertise, the client’s medical device was approved by regulators and was able to be commercialised successfully. Our ability to work with the client to obtain regulatory approval and its expertise in product development and compliance reduced the time to market for the client’s product, resulting in a successful partnership. 

For more information on how else Vestech Medical can support you,

see the links below.