Posts tagged with
“supply chain”

1 projects are tagged with “supply chain”.

As a medical product moves through development to production stage, establishing  supply chain controls to ensure reliable suppliers is critical to satisfy regulatory requirements for your device. ISO 13485:2016 has specific language around supplier controls that needs to be addressed in your QMS. It includes the additional requirements of supplier performance evaluation and controls appropriate […]

In the early stages of medical device development, it is usually sufficient to secure pre- production quantities through a simplified procurement cycle. A specification, a quote, a purchase order and a certificate of conformance —what other paperwork is needed? Why clutter up a simple, well defined process with other documents and paperwork?

Most boutique medical device design and development companies do not have an FDA registered, ISO 13485 compliant medical device manufacturing facility co-located with designers and engineers.  StarFish Medical Founder and President, Scott Phillips, believes this investment helps StarFish Medical uniquely tackle challenges and deliver innovation while providing fixed prices to clients.