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.
-
Expedited Access Pathway (EAP) is promising for timely approval and access to devices for life-threatening or irreversibly debilitating conditions.
-
Recent report on policies and initiatives claims the FDA device arm (CDRH) medical device approval process is much faster than five years ago.
-
Sketch to Launch commercialization process for medical devices guides translational services to the medical industry.
-
Advice, implications and examples for best time to implement a medical device Quality Management System in US, Canada and Europe.
-
Meeting with the FDA can put almost everybody in the company in panic mode. Benefits of FDA meetings and what to expect.
-
Medical device labeling includes all information provided with the device. Article identifies jurisdictions and associated “do’s and don’ts”.
-
UDI compliance: What does that mean for your products and your company? Link to additional information about UDIs on the FDA website.
-
Interview with Larry Spears, Former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations on prep for regulatory submissions.
-
Health Canada has announced online publication of Regulatory Decision Summaries (RDS) and a list of decisions under review.