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.
-
FDA inspection of our Quality Management System (QMS) and 2 medical devices that are contracted to StarFish Medical manufacturing.
-
Exploration of applying IEC-62366-1:2015 or human factors engineering to the design of medical devices compared to the FDA guidance document.
-
Did you know that this year FDA’s Human Factors Premarket Evaluation Team have a priority review hit-list for medical devices?
-
Engineers, regulatory advisors, and patent filing teams should review the MAUDE database as part of development and due diligence process.
-
9 ways a Medical Device development project project manager (PM) is critical for medical device development, and manufacture.
-
Safety implications to choosing lithium batteries in medical devices as well as practical business implications. Avoid these pitfalls.
-
To adapt project management of innovation for medtech product development, use Attitude, Building (and testing), Communication and Definition.
-
Sometimes the best way to secure regulatory approval requires the project manager to build a different box.
-
Good medical device project managers say “No” and they say it often. Truly great project managers find ways to say “Yes”.