Product Development

Pre-Production

It is a complex world out there in Medical Devices, we know that the job isn’t done when the project is in pre-production stage. A successful product design must take into account many aspects before it reaches the market, especially if the product will reach Global markets. Stortford Medical has the experience you need  to address the Regulatory maze:-

 

· FDA Pre-market Approvals

· CE Marking for Europe.

· UL, Fire safety.

· Clinical Assessment

Production

Stortford Medical can help you move your product into production, sourcing material suppliers, manufacturers, 510(k) approvals and preparing import documents. A good design does not end with production. In today’s medical market, the need for post market surveillance and monitoring of product quality is a top priority. We can help you design the monitoring and surveillance plans that you need to stay on top.