information-technology software 
FDA Law Blog
MAY 6, 2024
FDA interprets the “software” definition to include software that is firmware or programmable logic in addition to software in a medical device (SiMD) or software as a medical device (SaMD). update servers, network connections, cloud, etc.) are cybersecure.
Rethinking Clinical Trials
JUNE 15, 2023
They joined to share information on the FDA’s approach to clinical decision support (CDS) software, including the agency’s recently released guidance , which helped stimulate a discussion on the associated considerations for embedded pragmatic clinical trials. The FDA focuses its oversight on a subset of digital health technologies.
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Pharmaceutical Technology
SEPTEMBER 7, 2022
Pharmaceutical Technology has listed the top patient adherence pharmaceutical companies based on our intel, insights and decades-long expertise in the sector. The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing decision. Patient adherence.
Pharmaceutical Technology
OCTOBER 13, 2022
Asset finance businesses are inherently complex, so when it comes to implementing new software, there’s a lot that can go wrong. Outdated technology forces businesses to work within its constraints, instead of doing what’s best for the business. Explaining the why of new software. Michael Mousdale, project manager at Alfa.
pharmaphorum
SEPTEMBER 28, 2020
The FDA has launched its Digital Health Center of Excellence (DHCoE), as the agency continues with its commitment to advancing use of technology such as mobile health devices, software and wearables to create medical products. The post FDA launches Digital Health Center of Excellence appeared first on.
FDA Law Blog
APRIL 25, 2023
If a device uses software that connects to the internet, it is most likely a cyber device and subject to new section 524B of the FD&C Act, “Ensuring Cybersecurity of Devices.” The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents.
pharmaphorum
FEBRUARY 8, 2022
Glasgow, UK (24th November, 2021) – Formedix , a leading provider of clinical trial software solutions, announces the launch of the Formedix ryze Community, to provide their customers with a location to collaborate, expand their knowledge and share information. 30 seconds Intro to the Community. 30 seconds Intro to the Community. “We
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