Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Standards

Product Development

Medical electrical equipment IEC 60601 series

Quality Mng. System ISO 13485

Biocompatibility ISO 10993-1 series

Software Life-Cycle IEC 62304

Usability IEC 62366

Risk Management ISO 14971

Embedded software

The Organisation for Professionals in Regulatory Affairs

19

Standards

Product Development

Health Software IEC 82304-1

Quality Mng. System ISO 13485

Software Life-Cycle IEC 62304

Usability IEC 62366

Risk Management ISO 14971

Standalone software

The Organisation for Professionals in Regulatory Affairs

20

10