EUDAMED is planned to become mandatory by Q4 2024!
July 18, 2022
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July 18, 2022
March 18, 2022
What is a 510k? Who needs to submit a 510k? When is a 510K required? and more questions are going to be addressed in this document!
March 18, 2022
FDA has released a draft guidance document for industry to guide sponsors on evaluation of device software’s safety and effectiveness. “The recommendations in the new draft guidance document pertain to device software functions, including software in a medical device (SiMD) and software as a medical device (SaMD)”. The new draft guidance has in depth recommendations for every Software documentation element needed to be included in any premarket submission.
March 9, 2022
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.
February 17, 2022
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.