IEC 62304 requirements relevant to software development and planning, software maintenance, software risk management, configuration management and problem resolution. The requirements and processes needed are interrelated and interacted to one another and can be addressed collectively for a safe and compliant medical software.
Working together with your team from early stages of your Medical Device Software to ensure that your medical software meets the requirements of IEC 62304, Medical device software – Software life cycle processes.
We are well equipped to support your team establishing all technical documentation needed to address the requirements of the standard in addition to a self-assessment informative report for you to use as part of your technical file.