"Understanding SaMD: Navigating the Significance and Meeting Compliance Standards"

In the past decade, software has made its way into pretty much every industry, completely transforming them, including healthcare and automotive. People like doctors, patients, and regular folks like you and me are directly benefiting from digital advancements. Now, when it comes to the safety aspects of human well-being, each industry has its own set of standards that need to be met, but these standards can vary from country to country. For instance, ISO 26262 focuses on ensuring functional safety in vehicle development, while ISO 14971 deals with the combination of software and hardware in medical devices.

Smartphones, social media, and the sharing economy have completely changed the way we live, work, and have fun. But their impact goes beyond just that - they are also driving incredible advancements in the field of medicine. Think 3D printing, point-of-care diagnostics, robotics, bioinformatics, synthetic biology, and genomics, just to name a few.

Software is revolutionizing how medical professionals practice, how consumers take charge of their own health, and how patients and providers connect. And one of the most exciting developments in digital health technology is software that can perform complex medical functions - we call it software as a medical device (SaMD).

SaMD can diagnose illnesses, recommend therapies, and help with clinical management.

To be more specific, SaMD refers to software that's designed for medical purposes and isn't part of a medical device's hardware.

For example, let's say there's a mobile app that runs on a smartphone and checks the user's heart rhythm to detect irregular heartbeats. That app is classified as SaMD. It runs on a regular platform and doesn't need any physical device.

Here are a couple more examples:

- Software that uses personalized patient data to estimate the right dose of a drug.

- Software that analyzes MRI images to detect and diagnose strokes.

However, there are cases where software doesn't qualify as SaMD, such as:

- Electronic health record systems.

- Software that operates a pacemaker.

- Software that controls the motors of an infusion pump.

So, SaMD is all about software that serves medical purposes without being part of a specific medical device.

Why is compliance important?

Compliance is essential for a few reasons. First, it helps improve patient satisfaction and reduces infection rates by ensuring proper practices and patient safety. Second, it involves following both external and internal controls. Lastly, when it comes to medical devices with software, it's crucial to establish their safety and effectiveness. This means understanding what the program is designed to do and demonstrating that its use achieves those goals without posing unacceptable risks.

To implement compliance effectively, we need to assess different levels of risk severity, which is also known as SamD categorization. Taking into account the software's functionality and its safety implications, the categorization of SaMD can be delineated as follows :

Two primary standards governing SamD compliance are IEC 62304, evaluating software development processes' safety and risk, and ISO 13485, covering quality management in organizations.

ISO 13485 emphasizes patient safety and requires organizations to implement processes compliant with regulatory requirements in their target markets. It includes a risk-based approach to managing processes, setting quality targets, defining necessary resources, and ensuring proper product planning and monitoring.

In addition to the standard ISO requirements, ISO 13485 delineates the following key provisions:

1. Adoption of a risk-based approach to oversee pertinent processes across the organization.

2. Establishment of quality objectives and conducting management reviews to ensure their execution.

3. Explicit definition of resources necessary for sustaining the Quality Management System (QMS), encompassing infrastructure, human resources, and the work environment.

4. Comprehensive product planning, encompassing quality requirements, documentation, handling procedures, and traceability, notably including the Software Maintenance Plan.

5. Vigilant monitoring, measurement, analysis, and improvement initiatives to uphold the conformity and effectiveness of the QMS

Common compliance issues identified by regulatory bodies like the FDA are :

• design controls

• corrective and preventive actions (CAPA)

• handling of complaints

To mitigate these issues, organizations can implement practices such as

• Traceability to be achieved by linking product features to architectural components and subsequently associating them with development (code) and validation (test) tasks.

• Customer complaints are received, logged, tracked to resolution, and feedback is provided to the customer. These complaints typically adhere to service level agreements (SLAs)

• The root cause of the complaint undergoes analysis utilizing methodologies such as the 5 WHY, Pareto, or Fishbone techniques, and the resulting insights are disseminated within the team. Additionally, comprehensive descriptions of corrective actions (CA) and preventive actions (PA) constitute an integral component of the documentation process.

Once the categorization and compliance standards are established, the subsequent consideration pertains to the timing of implementation. ISO 13485, in conjunction with IEC 62304, should be meticulously applied and adhered to for SaMD classified as Type II (b) and higher. Conversely, for SaMD categorized as Type II (a) and below, there may be scope for more adaptable compliance requirements

Ultimately, as solution providers in the medical field, it's imperative to prioritize human safety when developing and implementing SaMD solutions.

Disclaimer : The information provided above are my understanding, views and readings of SamD content online (references as below) and the same should not be construed as professional advice.

References :

Sl No	Links
1	EU Medical device regulation
2	ISO 13485
4	FDA - Medical Devices regulation
5	IEC 62304