It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedTech Intelligence presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.
Technology should streamline the healthcare process for both patients and clinicians.
Companies should not underestimate the importance of investing in user experience design.
As software becomes more complex and connected, device manufacturers must address more risks.
Human factors addresses not only the obvious or physical, but also digs deep.
FDA prioritizes an A-list and B-list for the guidance documents it plans to publish in FY 2017.
To truly understand device use scenario, one must observe with intention.
The unpredictability of the process can make it difficult to stay on track throughout every phase.
The agency addresses design and manufacturing considerations, along with device submissions for product approval.
A look at some common mistakes medical device companies make when approaching risk.