How to choose ISO 13485 QMS software in 2026

For medical device companies looking for electronic quality management system (eQMS) software in 2026, evaluating solutions based on ISO 13485 compliance functionality can offer numerous strategic advantages.

The ISO 13485 standard is an internationally recognized foundation for quality management in medical device manufacturing which is required by regulatory agencies in Europe, Canada, and across the globe.

It forms the basis of the requirements of the MDSAP program.

And, crucially, the launch of the FDA's QMSR in February 2026 brings U.S. regulatory requirements for quality management systems strongly into line with ISO 13485 best practice.

ISO 13485:2016 is therefore the undisputed king of global medical device quality best practice, building on the broad foundations of ISO 9001 for the unique demands of the medical device world.

But ISO 13485 compliance is far from easy without the right tools in place. In this post, you'll learn how to evaluate ISO 13485 QMS software and the key features to look for in 2026.

Finding compliant ISO 13485 software for your QMS

The ISO 13485 standard is a prescriptive framework to meet the requirements for a QMS in the medical device industry. QMS software is built on the ISO 13485 framework to support quality control, operational efficiency, regulatory compliance, and the manufacture of safe medical devices.

Any QMS software designed for medical device manufacturers should offer built-in support for the adoption of the ISO 13485 framework methods and processes. While ISO 13485 has similarities to other international standards for quality management in highly regulated industries, it has unique requirements for QMS documentation and system validation. The best quality management software for small-to-mid-sized medical device manufacturers in 2024 is defined by 3 main features: simplicity, scalability, and reliability.

1. Simplicity

ISO 13485:2016 introduced new requirements for software validation. According to the regulation, any application used to support medical device manufacturing or development requires validation. Organizations should take a risk-based approach to prioritize quality system software validation. Validating your QMS can reduce regulatory and safety risks by ensuring useful documentation and safeguards

While there are clear quality benefits to system validation, it can also present resource barriers for early stage medical device startups. Without full-time IT resources, it's necessary to outsource software validation and revalidation processes to a trusted vendor. The best QMS for ISO 13485 should offer simplicity in fast, cost-effective validation and up-to-date packages which can be executed with a minimum amount of resources. The principle of simplicity should also guide your search for the best solutions which offer extensive features at an affordable cost without having to dedicate full-time IT staff to run the system.

2. Scalability

Organizations often overlook the key factor of an ISO 13485 compliant eQMS's scalability when assessing their options, yet this is a critical aspect to consider. Scalability is an especially important factor for companies with planned growth. A system should be sufficiently robust to comply since regulatory agencies don't consider the size of your company during the pre-submission process for devices.

During the beginning phases, your QMS software should offer basic components for document control, training, and risk management. As you grow, the eQMS should expand to cover testing and other procedures to streamline product submission. Acquiring software based on ISO 13485 standards can facilitate the process of scaling compliance and quality during growth phases.

Your system should accommodate your current needs and offer an expanded feature set as your needs evolve. The best ISO 13485-compliant systems can increase market valuation by providing the potential for easy data export if your organization is sold to a larger market player.

RELATED READING: ISO 13485 compliance checklist

3. Reliability

The majority of medical device manufacturers are reliant on a small, global talent pool for research and development. According to MedPac, 73% of device companies have 20 or fewer employees. A cloud-based ISO 13485 QMS software is a critical tool for effective collaboration among a distributed workforce.

When evaluating the best vendors, consider their uptime, or record of system availability, to ensure your eQMS will be reliable. Nothing is worse than getting 15 seconds in front of an executive for a signature and finding your system is down.

Mobile functionality is also a critical feature for many startups and small firms in highly regulated industries. Finding a solution which works seamlessly on mobile devices can streamline productivity for small, busy teams. Mobile features for document review and approval can be a significant benefit if your executive team is continuously traveling to raise funds.

Make 2026 the year you get ISO 13485 QMS software

Finding the best ISO 13485 QMS software is an essential benefit for medical device manufacturers at all stages of the product lifecycle. Regulatory agencies dedicate significant effort to ensuring medical device safety during premarket approval processes. A QMS software can establish a stable baseline of data to demonstrate compliant, quality-driven operations and safe device manufacture.

ISO 13485:2016 significantly expanded requirements for system validation, including an explicit requirement for compliant organizations to obtain QMS validation. Qualio's medical device quality and compliance platform includes updated validation packages for clients to execute to maintain continuous compliance with regulations for medical device safety. Qualio is built to ISO 13485 standards for medical device manufacturers and organizations in highly regulated industries to create a simple, scalable approach to quality-driven culture.