Congratulations. You’ve created all of your design inputs, defined the outputs, and conducted design verification. Your design is complete and you are ready for production. Now it’s time to make sure those design outputs are correctly translated into written production specifications.

These specifications are typically composed of written documents, including:

 

• Product and assembly drawings
• Material specifications
• Inspection and test specifications
• Manufacturing instructions
• Training materials
• Drawings (tooling, fixtures, product, etc.)
• Component procurement procedures
• Workmanship standards

In some cases, the design transfer may come before validation when your ability to produce a prototype or production-level device cannot be achieved in another manner.…

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Earlier (in a previous post) we addressed the importance and necessity of design control planning. Now let’s talk about the specific design inputs that need to be defined and tracked.

Of all the design control activities, developing a solid foundation of requirements is the most important. Why?…

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Coding changes. Materials substitution. Design refinements. UX improvements. Manufacturing changes.

Medical devices, like all products and software, are constantly evolving. Yet, due to the nature of medical devices and their impact on personal health and safety, the entire product life cycle of a device must be carefully documented. It’s an easy thing to overlook.…

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