The IEC 62304 standard outlines the life cycle processes, activities, and tasks that are required for the safe design and maintenance of medical device software.1 Adherence to the standard process ensures that necessary actions and precautions have been taken to prevent the risk of an event involving a threat to the life of a patient.
When is IEC 62304 applicable?
- The software is itself a medical device.
- The software is an embedded or integral part of the final medical device.
Embedded and Stand Alone
Embedded software or Medical Device Software is software that is part of a physical medical device and is designed for a specific hardware.
Standalone software or Software as a Medical Device (SaMD) is Software as a Medical Device, or SaMD, can be described as a class of medical software designed to carry out one or more medical functions without the need for actual hardware.
Status of IEC 62304
Developed by the International Organization for Standardization, the IEC 62304 standard defines the process and objectives for the safe design and maintenance of an SaMD. The outlined objectives in the standard touch holistically cover the entire Software Development Life Cycle(SDLC) process from planning and use case analysis to quality assurance and deployment.
What does an IEC 62304 certification mean for our partners?
- Compliance to IEC 62304 instills our partner’s trust in our core values of safe development & maintenance of an SaMD.
- Audits of the software processes, documentation, and quality have been carried out based on the standards laid out by the IEC 62304.
- If any risks arise during the development of the software, compliance to IEC ensures that all risk control measures throughout the development process are well defined, and in place.
- In most cases, during software development, using Off the Shelf code(SOUP) does reduce the task of the developers but a comprehensive risk assessment has to be carried for the code to ensure so threat to the device. This might add to the concern of a partner. Adhering to IEC 62304 reduces the burden of risk assessment.2
- The Software Development Process at Wellthy is designed to meet the requirements for an IEC 62304 certification , thus our partners can scale the Digital health solutions worry free.
References:
1. https://webstore.iec.ch/preview/info_iec62304%7Bed1.0%7Den_d.pdf
2. https://softcomply.com/importance-iec62304-compliance-2/
