Medical Device Standards
Plain-language compliance guides for the standards that matter — written by engineers, for engineers.
New regulations — elevated priority
Classic medical device standards
Med
EU MDR
Medical Device Regulation EU 2017/745 — classification, conformity assessment, technical documentation.
Read guide →MedIEC 62304
Software lifecycle requirements for medical device software.
Read guide →MedISO 14971
Risk management — hazard identification, risk controls, and residual risk evaluation.
Read guide →MedISO 13485
Quality management systems for CE marking and FDA registration.
Read guide →MedIEC 60601-1
Basic safety and essential performance of medical electrical equipment.
Read guide →MedIEC 62366-1
Usability engineering for medical devices.
Read guide →ProMDR Post-Market Surveillance
PMS-Plan, Reklamationsmanagement, Vorkommnismeldung und PSUR nach MDR Art. 83–88.
Read guide →