CriTech and Realtime are Streamlining Medical Device Development CriTech is excited to announce our new strategic alliance with The Realtime Group, an ISO 13485 certified
Additional Information (AI) Requests are a part of FDA’s procedure to provide a medical device company with an opportunity to submit additional information missing from
The U.S. Food and Drug Administration (FDA) issues Additional Information (AI) Requests during the review of medical product submissions, such as Investigational New Drug (IND)
Synopsis : Cybersecurity for medical devices is required according to the U.S. Food and Drug Administration (FDA). Medical device manufacturers must comply with federal regulations.
Synopsis : The benefits of Independent Verification and Validation (IV&V) of medical device software are many. The purpose of this paper is to discuss the
