s2m Forum


Tailoring Medical Device Product Development

My medical device company has a single process for product development and design controls, regardless of the countries of launch, device classification, or risk. Question: How can the product development process be customized for each project without compromising design control? Answer: First, it is important that an organization have a single process for all its…
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Medical Devices: Control is Not the Same as Innovation

In the design of medical devices, design controls are not necessarily the same as a product development process. A quality management system requires that a process and controls be in place and be documented. Its intent is to guarantee that product development is documented for traceability and that products are made in a consistent manner….
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