Usability Engineering for Software as a Medical Device
Usability engineering for SaMD under EN 62366-1 and MDR Annex I. Screens, interaction flows, error messages, alert fatigue, and the Rule 11 connection.
Category
Cybersecurity & Data Protection
11 in-depth guides in this cluster
Usability Engineering for Mobile Medical Apps
Mobile medical app usability under EN 62366-1 and MDR Annex I. Why connected-device teams skip app usability and why the 80-year-old user breaks the assumption.
Usability of Instructions for Use (IFU)
Usability of medical device instructions for use under EN 62366-1 and MDR Annex I §23. Why a 150-page IFU fails and how to run the real summative test.
GDPR and Medical Devices: Data Protection for MedTech Startups
GDPR medical devices data protection is not a parallel workstream. It belongs inside the cybersecurity risk file and the MDR Annex I §17 documentation.
Health Data Under GDPR: Special Category Data Processing
Health data GDPR special category processing sits above the ordinary GDPR bar and shapes what a MedTech startup can do with clinical data by design.
Data Protection Impact Assessment (DPIA) for Medical Devices
DPIA medical devices GDPR obligations overlap the cybersecurity risk file and the ISO 14971 risk file. Build one asset inventory and let it feed all three.
Cybersecurity Labeling for Medical Devices
Cybersecurity labeling medical device MDR requires IFU statements on minimum IT, user duties, operating environment, and end-of-support date under Annex I §23.4.
Hospital IT Requirements and Your Medical Device
Hospital IT requirements medical device: MDS2, HIMSS, network diagrams, SBOM, and vulnerability process. Prepare the pack before the procurement meeting.
Cybersecurity Certification Schemes for Medical Devices in Europe
Cybersecurity certification Europe medical device: EU Cybersecurity Act, ENISA, EUCC. What applies to MedTech, what is still emerging, and what is mandatory today.
7 Cybersecurity Mistakes MedTech Startups Make Under MDR
Seven cybersecurity mistakes MedTech startups make under MDR, drawn from audits across 50+ certifications, with concrete fixes for each one.
Cybersecurity Compliance Checklist for Medical Device Startups in 2026
The phase-by-phase cybersecurity compliance checklist startup 2026 teams use to map every line item to MDR Annex I, 81001-5-1, MDCG 2019-16, GDPR, and 14971.