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.
-
Qualifying for FDA Medical Device Development Tools (MDDT) program, categories, history, benefits, CDRH Qualification and Decision Framework.
-
5 FDA Inspection tips from our QA/RA experts help make FDA inspections efficient, effective and successful.
-
How QA/RA provides value to medical device project development projects and helps support Product Development and Manufacturing teams.
-
Medical Device Product Development Tips from experts covering engineering, design and development in Phase One of Development.
-
Areas to be considered in Summative / Human Factors Validation planning, include test environment, and user profile review.
-
5 reasons Human Factors remain important in medtech despite technological advancements like Artificial Intelligence (AI).
-
Medical device regulatory and QMS hidden costs can often be avoided when projects are well defined early to understand and know the costs up front.
-
Analysis of FDA draft guidance "Decentralized Clinical Trials for Drugs, Biological Products, and Devices."
-
Company values that StarFish employees use most to develop better medical devices include looking deeper, cutting to the chase and getting better.
