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Written by Paul Brown Last updated 21.06.2025 3 minute read

Considerations When Developing Software as a Medical Device

Learn key considerations for developing Software as a Medical Device (SaMD) in England. Explore MHRA & UK MDR compliance, clinical evaluation, usability, interoperability (FHIR), DTAC, cybersecurity, and how SIXB supports SaMD development.

Written by Paul Brown Last updated 21.06.2025 5 minute read

Understanding What Classifies Software as a Medical Device In England

Understand Software as a Medical Device (SaMD) classification in England. Learn about Class I, IIa, IIb, III, MHRA regulations, CE marking, and how SIXB supports digital health innovators with SaMD development and compliance.