QMS for Healthcare Software
Article 10 of the MDR specifies a set of criteria for Quality Management Systems that manufacturers in the industry must adhere to. The regulation mandates that manufacturers develop, maintain and continuously improve a QMS that aligns with the MDR requirements. Additionally, it stipulates that the QMS must be appropriate to the risk classification and nature of the device. But what implications does this have for Healthcare Software and/or Medical Device Software Organizations? Are the same regulations applicable? What variations exist? Are there any exemptions?
Software Updates
To begin with, every organization is unique and so should be its approach to implementing a quality management system. Unlike traditional manufacturing processes in the healthcare industry, Healthcare Software development involves processes where software is continuously updated and modified based technological advancements as well as on user feedback. This means that linear processes typically implemented in a traditional QMS will most probably have an alternative approach and be more flexible in Healthcare Software.
Risk Management
The potential consequences of software failures can impact patient safety directly, making it essential for organizations to implement strict risk management processes. This includes not only identifying and mitigating risks during the development phase but also continuously monitoring and managing risks post-deployment. Standards such as IEC 62304 emphasize the need for a structured risk management approach that is integrated to the software development lifecycle, in an effort to ensure that users’ safety is prioritized at every stage.
Regulatory Compliance
In Europe, Healthcare Software organizations are subject to several regulatory requirements that mandate or recommend the implementation of a Quality Management System that records the documentation practices specific to software development: functional requirements specifications, source code, design documentation, testing protocols, user manuals, change logs etc, must be documented, easily available and retrievable.
Continuous Monitoring
As mentioned previously, unlike traditional healthcare products, Healthcare Software requires ongoing monitoring and updates after deployment. A QMS for Healthcare Software should include mechanisms for continuous performance monitoring, user feedback collection as well as post-market surveillance to identify and address issues that may arise once the software is in use.
Data Security
When integrated with healthcare systems such as electronic health records, Healthcare Software face additional complexity challenges in terms of data security. Such scenarios require the implementation of solid testing and validating/verifying protocols as well as strict protocols for managing data privacy.