Let's get down to it... Both are actions that are required by the user in order to use the device however the subtle nomenclature difference can be misleading. The reality is that the subtlety can have huge impact on the use of a combination product. If a device is not " primed " correctly, it might not be providing the full dose. The user may perceive that the device is functioning and a dose has been delivered however the device might only deliver residual medication left

Probably not but maybe? The only time I check the expiration date is when I open the fridge and see something that's been there for a long while. But I don't deliver healthcare and thankfully, healthcare practitioners are a bit more conscious than I am. The purpose of an expiration date is to indicate the period during which the product is expected to remain stable and retain its identity, strength, quality, and purity when stored under the labeled storage conditions. For

If the devil is in the details, redemption lies in the oversight of those details—especially when it comes to successful product design. Designers and manufacturers focus on details such as interface design, user interaction, and testing because users of all levels demand products that work easily and reliably. In the medical device industry, those details take on life-or-death importance.  Furthermore, a user’s behavior is directly influenced by the user interface design. M

It's written in the IFU to be XYZ, therefore its the "law." Even though a HFE participant was able to achieve success in a particular task, it could be scored as incorrect in a summative/validation human factors study if the participant did not follow the exact steps as outlined in the instructions for use. Insert IFU icon

What's the difference and why I should care? Defined, ISO 14971 Risk Management for Medical Devices is the seminal and definitive risk management standard. Following this standard is not optional in medical device design. This standard specifies the normative requirements for a comprehensive, life-cycle risk management process. The technical report ISO TR 24971:2020 is the companion document that guides the application of those requirements. The basis for Use Failure Modes