Navigate Global Software as a Medical Device (SaMD) Regulations: Join the Online Training Course for Software Market Authorisation (March 26-27, 2025)
The "Market Authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course (ONLINE EVENT: March 26-27, 2025)" has been added to ResearchAndMarkets.com's ...
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New guidance launched for digital mental health technologies
Medical and Healthcare Products Regulatory Agency (MHRA) has released new guidance to help manufacturers meet UK medical ...
2025 Medical Device Cybersecurity Trends: What Will Shape The Industry?
What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.
OCT Medical Devices 2025: European AI Act compliance ‘not a cause for panic’
For those with Class IIa or above AI-related devices, compliance with the EU’s AI Act is likely to be akin to the EU MDR.
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Signifier Medical Technologies Secures European Union Medical Device Regulation (EU MDR) Certification for eXciteOSA®
The EU MDR certification is recognized globally for ensuring that medical devices meet stringent requirements for quality, safety, and clinical evaluation. The EU MDR certification paves the way ...
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Tracey Technologies pockets EU MDR certification for vision diagnostic
Tracey Technologies’ iTrace uses ray tracing technology to obtain precise measurements of the eye’s internal and external ...
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MHRA's AI as medical device pilot opens for applicants
and help inform an ongoing process to update regulations on guidance covering medical devices, software as a medical device (SaaMD), and AIaMD, according to Campbell. While the programme predates ...