I would probably say that this is more a case by case approach. For devices or features that are high risk, verifications and validation should be strictly separate to keep results trustworthy. But for lower risk features, you can afford…   Read more»

Medical device companies conduct internal audits to ensure compliance with regulations or standards. It is a great way to identify nonconformities before they become greater risks or to find ways for improvement. It is recommended for companies to conduct internal…   Read more»

How about instead you design the DHF around making it easier for the reviewer to read it in mind, rather than the regular documents? Starting with a one-page index of the most critical user needs and for each one, creating…   Read more»

Design control can actually be better for innovation, as it acts as a filter that would let ideas that wouldn’t pass regulation be rejected immediately, and the constraints would force for more unique innovations that still manage to be within…   Read more»

Meeting minutes are a useful tool for logging significant portions of a meeting, especially when discussing subjects such as design reviews/controls. This gives professionals the ability to keep tabs on a project’s progress through crucial milestones and data, especially during…   Read more»

Design inputs, control, or requirements are targeted for the intended use of the device in terms of the user and patient needs. Design control helps to indicate the user needs and the specifications associated with it to provide the correct…   Read more»

The Design History File consists of many documentations, figures, protocols, appendices, and miscellaneous items. For any medical devices, simple or complex, they should be extremely detailed to note everything that was done from the initial design to the finished product….   Read more»

Design teams should incorporate customer feedback into the design process very early on. They should not wait until the last minute to look or ask for feedback when time is ticking away and the deadline for the finished product is…   Read more»