DUBLIN--(BUSINESS WIRE)--The "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations" conference has been added to ResearchAndMarkets.com's offering. This intensive four-day ...

The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the ...

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical devices and IVDs have undergone a profound change. Manufacturers are now ...

For manufacturers of software-containing devices, a clear understanding of all relevant standards is crucial. This article takes a close look at the past, present, and future state of those standards.

Medical software is the backbone of modern healthcare, supporting electronic health records (EHRs), diagnostic systems, imaging technologies and embedded software in medical devices like pacemakers ...

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...

Dublin, Feb. 25, 2026 (GLOBE NEWSWIRE) -- The "Global Market Access for Medical Device Software Training Course (June 8th - June 9th, 2026)" training has been added to ResearchAndMarkets.com's ...

Medical device cyber challenges are among the most complex for manufacturers and healthcare delivery organizations for a variety of reasons, but there are some ...