Medical device development follows a well-established path. VSi understands the development process and works as a transparent partner to help you build a device that can be validated and manufactured at scale.
Prototyping
The development process begins with prototyping and proof of concept runs. During this phase, VSi provides input for designing for manufacturability and ensures that cost goals can be met at scale.
Development, Optimisation, Qualification
VSI is the industry’s leading ISO 13485 certified company. As such, VSI understands the importance of robust processes backed by complete documentation. VSI’s documentation supports efficient processing and regulatory requirements for qualified processes
Validation and clinical trials
There are several different paths for medical device approval and VSi is able to support customers needs. Device manufactures need a partner that understands risk analysis, has the systems in place for proper documentation and records control and can help support formal studies and experiments. VSi has successfully supported customers feasibility and clinical studies.