Jan 19, 2021 Ezra Kelderman

3 Major Regulatory Requirements for SaMD Companies

What are the major regulatory requirements for software as a medical device (SaMD) companies? 

Without an intimate understanding of these regulations, your SaMD startup or scale-up could face steep regulatory fines and/or delays to market.

In 2013, the International Medical Device Regulators Forum (IMDRF) devised and released guiding documents in support of SaMD compliance. In this document, IMDRF outlined the key definitions, risk categorization frameworks for SaMD, and quality management system (QMS) requirements.

The right QMS software will equip your growing SaMD organization with the tools and resources needed to prevent regulatory compliance and quality issues. 

Most major regulatory bodies — including the Food and Drug Administration (FDA) and the International Organization for Standardization (ISO) — will assume that your organization has already made investments in these areas. Moreover, when you pair a QMS with an in-depth understanding of major regulatory requirements for SaMD companies, regulatory compliance is almost guaranteed.

The Top Regulatory Requirements for SaMD Companies

As an industry-leading QMS provider, Qualio has helped hundreds of growing SaMD organizations orient toward rapid and sustained quality improvement and management. These SaMD companies enjoy the following benefits of a QMS:

  • Improved operational efficiency and effectiveness
  • Improved management-employee communications
  • Activation of evidence-based decision making
  • Activation of continuous improvement processes 
  • Increased profitability

“Companies that implement a quality management system that conforms to ISO 9001 typically improve the documentation of operating procedures, training, and procedures for corrective action,” reports Harvard Business School’s David I. Levin and Michael W. Toffel in Quality Management and Job Quality: How the ISO 9001 Standard for Quality Management Systems Affects Employees and Employers.

With the aid of a QMS, you can achieve compliance with the following regulatory requirements for SaMD companies.

1. SaMD Leadership

To start, executive management teams should provide expert leadership and governance over all product design and development processes of the SaMD. As such, executive teams must institute strategic decision making that outlines the current and future state of the SaMD organization. This extends to product compliance and quality.

According to a recent study, 86% of respondents say they receive strong or very strong support from their CEO and board on their company’s healthcare compliance efforts.

The right kind of executive-level support works to build a culture of quality. 

Instead of simply building products that meet regulatory expectations, employees feel motivated to build products that exceed both regulatory thresholds and quality objectives.

RELATED READING: Quality vs. Compliance: 5 Questions to Determine Your Focus 

2. SaMD Lifecycle Support

The appropriate implementation of product lifecycle support processes is paramount to the success of the SaMD. 

In this pursuit, organizations must commit to high-value activities related to product planning, risk management, document control, measurement, analysis, and improvement. A results-driven QMS can help here too by rapidly streamlining and automating various product lifecycle support activities.

In fact, maximizing operational consistency is a foundational component of an advanced QMS. The activation of a QMS requires SaMDs to define system requirements and best practices, including quality control and management review. 

Typically, SaMD organizations will institute standard operating procedures (SOPs) to ensure the appropriate activation/management of the QMS as it pertains to product support.

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3. SaMD Product Realization

Lastly, regulatory requirements for SaMD companies enforce appropriate product realization processes and systems. 

The purpose of SaMD product realization is to define and document product design activities. To this end, SaMD product design, developers, compliance officers, and quality teams should ask themselves the following:

  • How is the product being designed?
  • How is the product being developed?
  • How will the product be delivered?
  • How will the product be installed? 
  • How will the product be configured?

When the product is ready for consumer use, deployment activities, including installation and setup, should be clearly communicated to all stakeholders.

RELATED READING: How to Manage the Medical Device Software Development Process in Your eQMS

Qualio Supports Growing SaMD Startups

As technology continues to advance across the healthcare industry, software is taking on an increasingly prominent role in all products. SaMD companies will continue to invest in software tools and resources to guide product development and support.


To achieve the financial and collaborative benefits that a QMS offers, make sure your selection is right-sized for your company’s present state and goals. 

Qualio is the first cloud QMS designed specifically for the needs of life sciences companies with up to 250 employees. Our software is purpose-built to help startups achieve FDA and ISO compliance, enabling teams enter the market quickly and efficiently.

Are you worried about holes in your quality assurance plan?

If so, check out this free guide to learn how to create the perfect quality assurance plan to safeguard your growing SaMD organization from compliance issues and financial damage related to product development issues, recalls, and complaints.

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Published by Ezra Kelderman January 19, 2021