The International Medical Device Regulators Forum (IMDRF) defines Software as a Medical Device (SaMD) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”
- Software that is integral to a medical device (Software in a Medical Device)
- Software that facilitates the manufacturing or maintenance of a medical device
SaMD’s gaining currency in healthcare can be gauged from the fact that its market is expected to grow from US$ 18.48 billion in 2019 to USD 86.45 billion by 2027, at an estimated CAGR of 21.9%.
Earlier known as standalone software, health software, or medical device software, it can be implemented across several types of technology platforms such as medical device platforms, virtual networks, and commercial off-the-shelf platforms, among others.
Regulators across the globe have recognized the need to establish a common framework and principles to regulate SaMDs — to ensure patient safety while promoting innovation.
The IEC 62304, which takes a lifecycle approach to the development, deployment, post-market surveillance (PMS) processes for medical device software (Software in Medical Device), is also attuned for SaMD.
Therefore, SaMD developers, need to take cognizance of straddling the two worlds of software development and healthcare to plan their quality management system keeping the following four key factors in mind:
Factor #1 – Classifying the Risk Level of a SaMD
It is crucial that quality and safety leaders create a risk-based approach to the development of SaMD by classifying it according to applicable regulatory standards. IEC 62304:2016 provides a helpful flow chart that can help manufacturers to classify the severity of the risk of the SaMD based on potential hazards/quality events and the risk measures they plan to develop.
FDA’s Level of Concern is another resource that can help in assigning the risk level from minor to major, which is important especially in the event of a failure or defect.
As per the IEC 62304 standard, a SaMD can be classified as one of the following:
- Class A: No injury or damage to health is possible
- Class B: Can cause non-serious injury
- Class C: Can cause death or serious injury
FDA’s Level of Concern:
- Minor: When failures or inherent design flaws do not cause injuries to the patient or the operator.
- Moderate: When a minor injury to the patient or operator is possible due to a flaw or failure.
- Major: When a failure or flaw could lead to death or serious injury of the patient or operator.
By identifying risks, the company building the SaMD can also put in place mitigation strategies to lower the risks and improve response in case of any failure or flaw.
Factor #2 – Robust Document Management Processes
Creation and management of related documents for every stage of the development, deployment, and PMS process is an essential part of device classification. They should be easily accessible and traceable as the regulators will need them to review in case of any major issues. Therefore, the QMS should enable document management, which is a little more than file management in the cloud. A document management system enables collaboration, version control, archiving, reviews, approvals, and even deletion of documents as required, to meet regulatory requirements.
If your enterprise’s EQMS comes with an integrated document management system, it makes life easier for quality and regulatory leaders – by ensuring that the “single source of truth” is always just a few clicks away.
Factor #3 – Product Quality Management across the Product Lifecycle
Making quality a part of the organizational culture is essential for continuous improvement to minimize risks, reduce costs, ensure compliance, and increase customer satisfaction.
A QMS aligned to key regulatory standards across the globe such as FDA 21 CFR Part 820 and ISO 13485:2016, can also help with keeping track of (and implementing changes) evolving regulations.
According to the IMDRF guidance, the QMS for SaMD should facilitate processes that support the entire lifecycle of the software and is scalable. It should address the following quality management requirements:
- Robust quality processes right from product planning to providing a roadmap for the entire lifecycle
- Risk management to identify, assess, and control risks and hazards
- Document and record control
- Change management of configurable items such as the source code, releases, software tools, documents, etc.,
- Establish key performance indicators (KPIs) to assess the performance of the SaMD throughout its lifecycle
- Reports and dashboards to identify trends and effect continuous improvement
- CAPA to rectify issues in case of nonconformities
Next-Generation Cloud-Based EQMS for SaMDs with integrated risk management
The EQMS from ComplianceQuest is a cloud-based solution built on Salesforce and aligned with all key regulations to facilitate seamless compliance. It is a flexible and scalable solution that covers the entire lifecycle of SaMD and facilitates a risk-based approach to the development process.
Its modules for complaint management, CAPA, change management, document management, nonconformance, management review, risk, and compliance provide an end-to-end, integrated view of the quality workflow for SaMDs.
This can help various stakeholders including quality leaders, the regulatory affairs team and executive leadership get a holistic view of quality processes and metrics at every stage of the SaMD lifecycle. Overall, using a next-generation EQMS not only increases productivity and efficiency but also increases accountability and transparency.
The ComplianceQuest EQMS can help with
- monitoring and managing events and complaints
- conducting software audits
- using the findings to improve the product performance and minimize risks
- increase transparency
- enable real-world performance monitoring and ensure periodic updates
To request a demo of our solution, visit: https://www.compliancequest.com/online-demo