The most common question supply chain professionals get from clients is “How can we reduce the cost of this project?” Cost reduction is always a challenge – especially in a low volume, complex manufacturing environment.
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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 […]
A world class medtech supply chain is made on a foundation of controls, knowledge and planning. This blog takes a look at three key elements a seasoned buyer would use to achieve maximum potential: Lead Time, Quoting/Planning, Paperwork Accuracy.
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.
Manufacturing Director Jason Dolynny and Supply Chain Manager Laura Meyer answer a dozen questions on contract manufacturing to help readers choose the right partner and get the most out of their manufacturing relationship. Bonus: a responsibilities checklist.
There are many hurdles when trying to get to market with small volumes. With careful planning and smart strategic decisions you can create an environment that enables controlled growth and provides targeted cost of goods solutions.