IEC 62304 Ed. 1.1 b - 2015 - Medical Device Software - Software Life Cycle Processes

The IEC 62304 Ed. 1.1 b:2015 standard defines life cycle requirements for medical device software, establishing a framework for safe design and maintenance. This consolidated edition incorporates the original 2006 release and Amendment 1 (2015), eliminating the need for separate purchases. Key features include:

Scope: Applies to standalone medical device software (SaMD) and software embedded/integrated into medical devices (SiMD).

Risk Classification: Defines three software safety classes based on potential harm, integrating with ISO 14971 risk management.

Life Cycle Processes: Covers development, maintenance, configuration management, and problem resolution, with specific deliverables for compliance.

Regulatory Recognition: Harmonized with FDA requirements and globally accepted for market clearance submissions.

Product Details
Edition:
1.1
Published:
06/26/2015
Number of Pages:
350
File Size:
1files , 7.1 MB
Note:
This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus[!mpn:11.040!][!gtin:9782832227657!][!author:iec!][!edition:1.1!][!pages:350!][!year:2015!]