Resource Centre
Discover a wealth of knowledge and insights from the experts at StarFish Medical. Our Resource Centre offers product development tips, reviews of new and cutting-edge technologies, and in-depth articles on regulatory updates and compliance in medical device development.
-
The Bleeding Edge explains how 510K cleared medical devices are clinically proven to improve patient outcomes and save lives.
-
The book Bad Blood eloquently demonstrates the importance of properly developing medical devices under ISO 13485.
-
6 benefits mean the FDA program for breakthrough medical devices may be your best regulatory option for novel medical devices.
-
FDA’s Early Feasibility Studies Program (EFS) is a great option in early stage development looking to advance your program by gathering data.
-
Proper research and communication with authorities in each country of interest will make Medical Device International Regulations smoother to navigate.
-
ISO/IEC 17025:2017 includes many changes. Three points to keep in mind: more options, involvement of risk, updates in current technology.
-
Kepner-Tregoe’s original Decision Matrix overview with tweaks to make it broader and more robust.
-
FDA Guidance on Additive Manufacturing (AM) – offers new ways to integrate parts not only for prototypes, but for final products.
-
11 medical device development mistakes that surfaced frequently in a variety of products. Avoid them to reduce cost and time to market.