supply chain

Posts tagged with “supply chain”

1 projects are tagged with “supply chain”.

Lindsey

5 Tricks that reduce low volume supplier lead times

Negotiating low volume lead supplier times is not without challenges. Vendors can look at low volume quantities or lower dollar value orders as less priority or of importance to fulfill.  Adding to this challenge, Just In Time (JIT) delivery is often used to meet on demand client sales orders. The pre-planned anticipated lead time in […]

Dana Trousil

First-to-Market Vs. robust commercialization: trade-offs, tips, and tactics

Bringing your medical device to market involves a lot of trade-offs. First-to-Market Vs. robust commercialization process. Do you launch quickly with a minimum viable product? There may be significant post-launch changes in order to be the first to market. Possible negative feedback from rushing to market may destroy any device adoption. Perhaps going through an […]

Kathryne Young

Establishing Supply Chain Controls to de-risk your 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 […]

Laura Meyer

Supplier Quality Agreement or Supply Agreement?

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?

Jason Dolynny

12 Design and Engineering benefits of co-locating medical device manufacturing

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.

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