How SaMD companies can use a QMS to improve regulatory compliance

Nearly a decade ago, the International Medical Device Regulators Forum (IMDRF) released its guidelines for Software as a Medical Device (SaMD). Because of this established guidance, most major regulatory bodies—including the U.S. Food and Drug Administration (FDA) and the International Organization for Standardization (ISO)—assume that your organization has already made investments in SaMD compliance.

Medical device manufacturers also need to follow specific guidelines enforced by the FDA and are recommended to incorporate elements of ISO 13485 (Medical Devices - Quality Management Systems) into their work processes. Unfortunately, achieving and maintaining regulatory compliance can significantly strain an organization’s internal infrastructure and resources.

The INDRF’s comprehensive guidelines include software and medical device principles that can be effectively applied to a SaMD QMS. Choosing the right quality management system (QMS) software will equip your rapidly expanding SaMD organization with the necessary tools and resources to prevent issues with compliance and quality. But without an intimate understanding of all regulatory expectations and a QMS solution specifically built for SaMD companies, your organization will almost assuredly fail to meet FDA requirements. It’s a problem far too many medical device organizations face on the path to regulatory pre-market clearance or approval.

As innovation advances across the life sciences industry, technology like QMS software is taking on an increasingly prominent role in all product lines. SaMD companies continue to invest in software tools and resources to guide product development and support. In fact, Harvard Business School reports that companies that have improved their documentation of procedures, training, and corrective actions are usually the ones who have implemented a QMS conforming to ISO 9001.

Other benefits of a QMS include:

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

With the aid of a QMS, you can achieve compliance, resulting in a clean “bill of health” from the FDA or other regulatory bodies.

Three critical areas increase success in reaching and sustaining SaMD compliance:

1. Start with leadership support for quality standards

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

In most cases, leadership teams understand the importance of quality and the cost-benefit of meeting (or exceeding) compliance standards. According to a recent study, 86% of workers with compliance responsibilities say they receive strong or very strong support from their CEO and board on their company’s healthcare compliance efforts. However, most leadership teams fail to relay the impact of quality and compliance to their employees.

To improve leadership support, start by encouraging increased employee accountability. Does your team understand the significance of quality and compliance? Do they understand the broader quality and compliance objectives of your organization? Does leadership oversee the careful alignment of organizational procedures and processes (formal systems) with day-to-day practices (informal methods)? Do they nurture and support a “quality mindset” culture?

Your executive leadership must empower employees to build products with quality top of mind. Consider establishing a quarterly “quality sync” between executive and managerial teams as a best practice. This meeting would foster discussion of what’s going on, how your leadership can fix any issues and remove blockers, and prepare goals for the next quarter. Use this as an opportunity to align on quality procedures and discuss any areas for improvement, paying close attention to any gaps in quality or compliance activities. Additionally, you should use your organization’s internal auditing process to gather information, make informed, data-driven business decisions, and discover continuous improvement opportunities.

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

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

2. Use eQMS software for efficient SaMD lifecycle support

The success of any SaMD product relies on implementing product lifecycle support processes. That means committing to high-value activities related to product planning, risk management, document control, measurement, analysis, and improvement. A results-driven eQMS can help streamline and automate your product lifecycle support activities.

In fact, maximizing operational consistency is a foundational component of an advanced QMS. Activating a medical device QMS require  defining system requirements and best practices, including design controls, quality control, and management review. Ensure the appropriate activation and management of the QMS by instituting standard operating procedures (SOPs) for consistent product support.

For 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.”

One way to set up effective systems, processes, and SOPs is by using the FDA’s Software Precertification Program (Pre-Cert 1.0) to benchmark the safety and efficacy of your SaMD. The program focuses on five major principles (“Excellence Principles”):

• Patient safety: By constantly verifying the continued safety and performance of SaMD, you protect the patients using the product.
  
  
• Product quality: Make sure the SaMD you’ve designed is high-quality and that its functionality is maintained throughout every single update.
  
  
• Proactive culture: Being proactive with quality in your company can help you avoid more significant issues down the road and identify potential problems before anything goes to market.
  
  
• Cybersecurity responsibility: Ensure the SaMD you’ve designed is as secure as possible to protect sensitive patient data from being accessed by the wrong people.
  
  
• Clinical responsibility: Patient care is vital, and SaMD is quickly becoming an integral part of that. If the software or apps aren’t of the highest quality, then the patients aren’t getting the best possible care.

Pre-Cert 1.0 is entirely voluntary and still a pilot program. However, successful completion helps to establish a compliance commitment to a culture of quality and organizational excellence (CQOE) as you monitor the safety, effectiveness, and overall performance of the SaMD. Compliance documentation for this certification can be stored in your QMS, granting your team access to everything needed to complete the application when it comes time to submit.

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3. Meet regulatory requirements for SaMD product realization

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

SaMD product realization aims 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? Consider its intended use and the best ways to design the product so it serves its purpose in the most efficient way.
  
  
• How is the product being developed? Consider who will develop the product, who will manufacture it, and any other factors here. Will it rely on any artificial intelligence or machine learning?
  
  
• How will the product be delivered? Determine the best way to distribute your SaMD. Will it be completely electronic? Does it need any compatible devices?
  
  
• How will the product be installed? Can the patient install it? Does a representative from your company need to be there for installation? Consider how user-friendly the installation process should be.
  
  
• How will the product be configured? Figure out the best way to configure your SaMD’s UX, so it meets your goals for the product. It should be user-friendly and intuitive. Also, remember to capture and document UX throughout product development to demonstrate appropriate human factors considerations.

When the product is ready for consumer use, deployment activities, including installation and setup, should be clearly communicated to all stakeholders. Using QMS software to help with documentation ensures that everything you need will already be stored in your system.

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

Close holes in your QMS with Qualio

Qualio is the first eQMS designed specifically for the needs of growing life sciences startups. Our software is built to help early-stage companies achieve FDA and ISO compliance, enabling teams to enter the market quickly and efficiently. From increased productivity and improved operational performance to evidence-based decision-making, our QMS supports SaMD’s quality and compliance pursuits. Additionally, our platform scales with your organization as it grows.

Need an eQMS for your SaMD company? Let's talk.