Jul 15, 2021 Kelly Stanton

Regulatory Expectations for Software as a Medical Device (SaMD) Startups

To ensure that products are safe and effective for use, medical device manufacturers need to follow specific guidelines enforced by the U.S. Food and Drug Administration (FDA). Unfortunately, achieving regulatory compliance is a task that can place significant strain on an organization’s internal infrastructure.

The complexity of the situation is magnified tenfold for Software as a Medical Device (SaMD) manufacturers. In recent years, the market has seen a cosmic shift in the number of SaMD startups. As a result, the FDA has introduced some major regulatory expectations for this burgeoning medical device category.

Without an intimate understanding of all regulatory expectations for SaMD startups, your organization will almost assuredly fail to meet FDA requirements. It’s a problem that far too many life sciences organizations face on the path to regulatory approval.

Fortunately, we’ve helped thousands of SaMD organizations navigate these turbulent waters. In this article, we’ve highlighted the three regulatory expectations that your SaMD startup should consider as you prepare to bring your product to market. 

3 Major Regulatory Expectations for Software as a Medical Device Startups?

Does your product fall under the unique SaMD category?

According to the International Medical Device Regulators Forum (IMDRF), a SaMD is “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”

Over the years, Qualio’s industry-leading electronic quality management system (eQMS) has helped many SaMD organizations in achieving rapid and sustained regulatory approval. From document management to data unification, teams rely on our eQMS to streamline many quality assurance and quality control processes.

Keep reading to learn more about the unique regulatory expectations for SaMDs.

1. Leadership Support

The key to securing a compliant future starts with your leadership team.

According to one recent study, 86 percent of respondents reported that their leadership team provides them with the support needed to activate a culture of quality across the life sciences organization. In most cases, leadership teams understand the importance of quality and the cost-benefit of meeting (or exceeding) compliance standards. 

However, most leadership teams fail to relay the impact of quality and compliance to their employees. 

Which begs the question: Are there gaps in your communication processes?

To drive improved leadership support, start by enforcing increased employee accountability. Does your team understand the importance of quality and compliance? Do they understand the broader quality and compliance objectives of your organization?

Executive leadership must empower employees to build products with quality top of mind. As a best practice, consider establishing a quarterly “quality sync” between executive and managerial teams. Use this as an opportunity to align on quality procedures, paying close attention to any gaps in quality or compliance activities.

2. Lifecycle Support

Since 2019, the FDA has been pilot testing its Software Precertification Program (Pre-Cert 1.0). Use this program to benchmark the safety and efficacy of your SaMD.

The program focuses on five major principles: patient safety, product quality, proactive culture, cybersecurity responsibility, and clinical responsibility.

It should be noted that Pre-Cert 1.0 is entirely voluntary. However, successful completion helps to establish an organizational commitment to quality and compliance as you monitor the safety, effectiveness, and overall performance of the SaMD. Of course, compliance documentation for this certification can be stored in your electronic quality management system (eQMS). That way, when it comes time for you to submit your application, your team has everything it needs to complete the application.

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3. Product Realization

Starting from the initial concept of your device, SaMDs must think critically about the product realization protocols and systems used. ISO 13485:2016 paints a clear picture of the product realization requirements SaMDs must follow to build a safe and effective product. 

However, many SaMD companies make the mistake of committing to paper-based quality management tools during the early stages of product development.

Unfortunately, these legacy tools do little to honor the product realization requirements enforced by the FDA. Additionally, such systems are prone to errors and, as a result, produce unnecessary delays. 

Qualio has fixed this problem by creating the first web-based eQMS platform. With Qualio, SaMD companies can seamlessly manage compliance and quality all within one easy-to-use system. 

How Does Quality Affect Software as a Medical Device Companies?

Qualio has helped thousands of SaMD companies manage and improve quality processes—and we can do the same for your growing medical device startup!

Are you getting ready to launch an all-new and innovative product? 

If so, we know that time is of the essence. That’s why we designed our QMS to ensure rapid and sustained quality improvement. 

From increased productivity and improved operational performance to evidence-based decision making, our QMS supports SaMD’s quality and compliance pursuits. Additionally, the tool will scale with your organization as it grows.


As an example, Linical recently migrated from a paper-based quality management solution to Qualio’s eQMS, and the results speak for themselves.

“You can get any document you need very quickly and present it within a matter of minutes,” says Tyler Cochran, executive director of quality at Linical Americas. “You can look at an SOP in Qualio, see the list of associated documents, and click hyperlinks to retrieve information immediately.” 

To assess the performance of your own QMS, we recommend taking our free self-assessment. This self-assessment allows you to see how your current quality processes stack up against industry best practices. 

Leverage these findings to take your quality processes to the next level!

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Published by Kelly Stanton July 15, 2021