Posts by Kathryne Young

Kathryne Young

Creating a Commercialization Vision

What is medical device commercialization and how can vision help you reach your milestones? Commercialization can mean many things. In general, it is the process of taking a medical device that is near the end of the development cycle and transforming it into a real product ready for market. It involves gap analysis, process development, […]

Kathryne Young

Lean for Small Scale Manufacturing

When most people think of Lean Manufacturing, they think of large, gleaming, gazillion square foot manufacturing spaces where every surface is clean, meticulously labelled and taped off.  Happy workers reach for their conveniently placed tools on their shadow boards and work on mistake-proof assembly stations. They think of Toyota, or Boeing, or any manner of […]

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 […]

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