eQMS (Software) vs. a Scalable, Compliant, High Value QMS: Know What You're Buying

Compliant Quality Management Systems (QMS) are essential for medtech innovators of all shapes and sizes to demonstrate to regulatory or notified bodies and auditors that the company is complying with legal requirements. In the United States, this means 21CFR820 primarily. In the European Union (EU), this means ISO 13485 and Medical Device Regulation (MDR) 2017/745. 

When companies purchase eQMS software in an attempt to help achieve that compliance, the assumption is often that it's equivalent to having a full fledged, compliant quality system. This is an erroneous, dangerous assumption. The reality? Buying eQMS software is not the same as implementing a right-sized, compliant quality system that fits your business. Think of purchasing an eQMS like buying a filing cabinet for document organization. It’s essentially a passive repository. 

Having a QMS isn't just about checking the quality box. Your QMS should be built into the foundation of your organization. It not only supports compliance, it supports a quality business. An eQMS can be a good first step, but it's only part of the equation. Know the difference between buying eQMS software and building compliance. 
 

What Regulators Really Want to See in a Compliant QMS 

QMS Execution and Documentation 

Regulatory bodies look at QMS execution, along with precision and rigor in documentation, not just infrastructure. The FDA, Notified Bodies, and even investors look for evidence that your organization is using your QMS appropriately and effectively. The FDA's Quality Management System regulation makes clear that regulators want to see that your QMS is fully implemented and integrated into your organization from product development to commercialization and beyond. [Note: “regulatory compliance” means compliance to the CFR. Compliance to the CFR means compliance to QMS requirements.] 

Evidence Generated 

Having procedures, templates, and workflows is only valuable if your organization can demonstrate that they're being followed and generating compliant, consistent outcomes. Regulators care about whether your QMS can produce evidence of process controls in active use. For example, a change in the size of a critical component or material used must be properly documented and readily available. Critical note: Regulators and notified bodies only care about data generated by clinically equivalent devices, tested in appropriate environments, conditions and scenarios for the device’s classification pursuant to 21CFR820 in the United States and pursuant to ISO 13485 and MDR 2017/745 in the EU. At the end of the day, data generated for a regulatory submission, or to defend your work in an inevitable post-clearance or approval audit, must be generated within a compliant QMS. 

Efficient Use of Capital in a Compliant QMS Increases Velocity, Value 

A compliant QMS should be right-sized and fit for your business. The goal is a fit-for-purpose quality system; lean but compliant, and scalable as your company grows. Early adoption of a thoughtful quality system approach supports smoother transitions into downstream milestones and phases including regulatory submissions, clinical trials, commercialization and beyond.  

For MedTech innovators, accelerating time to market is a competitive advantage. A sound, well-implemented QMS supports efficient use of capital, which can be a key concern for organizations and investors. Investors want their funding to accelerate progress, not pay for rework, remediation, or delays. 

Implementing a lean, right-sized QMS early helps avoid costly missteps. The earlier you start the right way, the less likely you are to have to stop and fix things (wasting precious time and money). A well-structured and implemented QMS minimizes costly rework, failed testing, or late-stage design changes. It also reduces the risk of regulatory setbacks that can delay funding milestones or market entry. 

Clinical and Regulatory Compliance Depends on Quality Infrastructure and Execution; Not eQMS Software

Clinical Studies Require QMS-Backed Execution 

Clinical studies are more than a protocol—they require QMS-backed execution. To generate clinically usable and regulatory submissible data, the device under investigation must be traceable to design controls, risk files, and required testing for the device and its intended use. 

A robust, compliant QMS ensures that clinical builds are consistent, changes are controlled, and adverse events are reported and investigated appropriately. Documentation is crucial to demonstrate the clinical equivalence of your device further supporting any testing data submitted for regulatory approval (per 21CFR820/MDR 2017/745) and any potential audit defense. This also applies to sponsor responsibilities if your organization is acting as a clinical trial sponsor, all of which fall under quality system oversight. 

Regulatory Submissions Are Built on Quality Documentation 

Regulatory submissions are built on quality system documentation. Whether 510(k), De Novo, PMA, or CE marking, regulatory bodies require evidence, not just outcomes. That evidence comes from your organization's QMS procedures, design controls, risk management files, and traceable verification/validation data. Without these documents being structured and compliant, even sound technology can face regulatory delays, rejections, or worse, post-market public warning letters, product recalls or shutdown orders. 

Evaluating eQMS Software: Ask the Right Questions  

When choosing an eQMS, ask these critical questions: 

1. Does the provider offer pre-written, regulatory-compliant procedures and templates, or will they need to be created from scratch? 
2. Will they provide support and assist with configuring workflows to your organization's specific processes and business needs? 
3. Is there a structured process that covers not just system setup but actual QMS implementation steps?
4. Is the eQMS software scalable? Can the system grow with your organization, supporting additional sites, users, and product lines?
5. Is the system designed to meet ISO 13485, 21 CFR Part 11, Cybersecurity, EU MDR, or other applicable standards? 
6. Does the eQMS software provider assist with validation of said software to meet regulatory requirements and shifts within them? 
7. Are there resources to ensure your team is trained on the quality system, procedures, forms, and templates effectively?

The Bottom Line 

An eQMS provides infrastructure, but it is not the QMS itself, let alone a compliant one. Without a right-sized QMS that is fully integrated into your organization, eQMS software is just a repository vessel. When evaluating QMS solutions, know the difference between buying eQMS software and building compliance. 

Your organization's quality system must be more than a checkbox. It should be a strategic enabler that grows with your company, mitigates risk, demonstrates compliance to legal requirements and helps secure clinical, regulatory, and commercial success. Approach eQMS as part of a broader fit-for-purpose quality system strategy, lean but compliant, and scalable as your company grows. 

In many cases, especially for startups, the most effective solution marries technology (eQMS software) with the actual execution and management of an effective, compliant quality system that is built into the foundation of your organization, producing evidence of process controls and attractiveness to investors or potential acquisitive companies. 

If you are evaluating eQMS software or systems, or working to build a right-sized, scalable QMS, the Veranex Medical Device Quality Consulting team is here to help. Contact us to discuss how we can support your MedTech quality system strategy, regulatory and commercial goals.

Ramona Field is Executive Director, Quality Systems at Veranex.