FDA has released a draft guidance document for industry to guide sponsors on evaluation of device software’s safety and effectiveness. “The recommendations in the new draft guidance document pertain to device software functions, including software in a medical device (SiMD) and software as a medical device (SaMD)”. The new draft guidance has in depth recommendations for every Software documentation element needed to be included in any premarket submission.
On March 24th, join us as MIDI Medical Device Development Corp. and RQMIS Inc. present in a live #webinar "The Innovation Roadmap™ for Medical Device Development: Fostering Innovation & Optimum Programmatic Direction Under Strategic #Regulatory Deployment". Presented by Christopher Montalbano, CEO, MIDI Medical Device Development Corp., and Barry Sands, President, RQMIS.
The UKRI funding and support program will help HealthTech SMEs access regulatory assistance and knowledge for medical technology and invitro diagnostics. The program also offers guidance and education on regulatory systems and an opportunity to engage with industry regulatory experts.
On December 1st, join us as MIDI Medical Device Development Corp. and RQMIS Inc. present in a live #webinar "The Innovation Roadmap™ for Medical Device Development: Fostering Innovation & Optimum Programmatic Direction Under Strategic #Regulatory Deployment". Presented by Christopher Montalbano, CEO, MIDI Medical Device Development Corp., and Barry Sands, President, RQMIS.