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.
-
16 things to consider for the Medical Device Regulations (MDR Deadline) and changes you need to make in your Quality Management System.
-
Advice to help companies determine when to start thinking about setting up a Startup Quality Management System.
-
The Bleeding Edge explains how 510K cleared medical devices are clinically proven to improve patient outcomes and save lives.
-
How to handle recent medical product development regulatory changes under the 21st Century Cures Act and device exemption list.
-
Highlights of lessons learned from 3 FDA inspection strategies and visits to medical device manufacturer and clients.
-
FDA inspection outcomes from 3 very different inspection preparation strategies with lessons learned from the inspections.
-
FDA inspection of our Quality Management System (QMS) and 2 medical devices that are contracted to StarFish Medical manufacturing.
-
How a mock FDA inspection led us to learn the secret to closing open CAPAs by 50%. Vesna Janic shares the story and her tips.
-
Interview with Larry Spears, Former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations on prep for regulatory submissions.