DTECHENGINEERING

Resources

Plain-language guides for early-stage medical device teams.

Standards at a glance

A quick orientation. Always work from the current edition of each standard.

IEC 60601-1Basic safety and essential performance of medical electrical equipment.
IEC 60601-1-2Electromagnetic compatibility requirements and tests for medical electrical equipment.
CISPR 11Emission limits and methods for industrial, scientific, and medical equipment. Referenced by IEC 60601-1-2.
IEC 62304Software lifecycle processes for medical devices.
ISO 14971Risk management for medical devices.
ISO 13485Quality management systems for medical device organizations.
EU MDR (2017/745)The European regulation for placing medical devices on the EU market.
MDSAPA single audit program accepted by several regulators, including the FDA and Health Canada.