One undeniable fact applies to all medical devices: No matter where they are in development, review, or their stage in production, eventually they’ll be used by people, for people.
Your responsibility is for the device to be properly used. This means figuring out the intended users, and then accommodating anyone who might ever possibly come in to contact with your product.
A protocol is involved. Can the product be used straight out of the package? Or do users need training?
The considerations are as numerous as different types of people. SpectraMedEx has seen it many times. We know the ropes.
We’ll create your usability engineering plan, conduct the study, and prepare it all for submission and medical device regulatory compliance review. If you’d prefer your team learn the process, we’ll teach them how to work it into a quality management system.
People are unpredictable. Your medical device can’t be. SpectraMedEx helps you remove any guesswork, regardless of who uses it along the way.