What is a Modern QMS?

For medical device companies, the role of the quality management system (QMS) has greatly evolved—in both form and function.

Where once there were only filing cabinets and paper-based systems, we now document, track, and ensure quality with tools like electronic quality management systems (eQMS). This digital transformation has enabled MedTech companies to gain critical insights into the performance of their devices that otherwise may have gone undetected. 

But even in a cutting-edge industry like MedTech, there comes a time when an evolution needs a little kick of revolution—and that comes in the form of modern software solutions that make teams work more efficiently and effectively. Yes, including a QMS. 

Let’s take a look at the current state of the QMS and which features make a modern QMS so powerful for medical device companies.

BONUS RESOURCE: Click here to download your free copy of our QMS Software Vendor Checklist.

Why do MedTech companies need a modern QMS?

Your QMS is critical to your success as a medical device organization. It enables you to accelerate product development, comply with regulatory requirements, reduce costs, and continually improve the quality of life for patients who need it most. 

However, it is still just one piece of the puzzle. 

Findings from the 2023 MedTech Industry Benchmark Report reveal that today’s teams are using an average of 9 different tools to manage their medical device product lifecycle. The study found that these tools are often used to manage a specific organizational process, such as:

• Enterprise Resource Planning (ERP)

• Customer Resource Management (CRM)

• Computer-Aided Design (CAD)

• Business Intelligence (BI)

• Quality Management Systems

In many cases, the number of tools continues to stack up when companies choose to use disparate tools (such as spreadsheets or single point solutions) to manage critical processes, such as:

• Document and Change Management

• Design Controls

• Risk Management

• Bill of Materials (BOM) and Product Management

• Training

• Corrective and Preventive Actions (CAPA)

• Internal audits

As companies grow and product needs change, MedTech companies are forced to manually stitch these solutions and processes together as best they can. 

While this approach may make initial sense for the day-to-day operations, the reality is that collectively managing these applications and systems is challenging and cumbersome—and the impact can be felt across all facets of your business. 

The disconnected approach to managing a medical device product lifecycle means:

• Employees are forced to manually duplicate work across multiple systems, creating inefficiencies and risk of human error. 

• Data begins to pile up in disconnected silos, resulting in decreased visibility and a lack of real-time data. 

• General purpose tools and disjointed spreadsheets aren’t built for a regulated industry like MedTech, making compliance more challenging than ever.

But what if there was a better way? What if you could avoid duplicating data, putting your company’s compliance at risk, and sacrificing team efficiency and time that could be spent elsewhere?

In the 2023 State of Medical Device Industry report, participants were asked, “What’s the one thing that would make your job easier or more effective?” Their response? Dynamic technology that simplifies and streamlines quality throughout the product life cycle. 

“More than anything, I’d like a system that links everything—absolutely everything, like product documentation—together,” said one survey-taker. “It would transform my job.”

What makes a QMS “modern”?

In order for a QMS to be considered truly-modern, it needs to be more than a standard electronic quality management system (eQMS). It needs to solve today’s problems, enabling MedTech professionals to do more value-adding work and reach new levels of true quality in product design, manufacturing, regulatory compliance, and risk management.

A modern QMS is a connected, cloud-based ecosystem that provides end-to-end management of all quality processes throughout the product lifecycle, from design and development to postmarket surveillance. 

It is a single source of truth that ensures everyone in the organization is working from the same set of data, reducing the risk of errors, inconsistencies, and compliance issues. And, most importantly, it is purpose-built for the rigors and regulations of MedTech.

Being able to share QMS data with the rest of the solutions that power your MedTech lifecycle is imperative to working faster, more efficiently, and staying compliant. That’s why a modern QMS comes with data-sharing capabilities, such as an export application programming interface (API), which is imperative because it enables you to share your QMS data with any 3rd party software that helps power your business.

With a cloud-based modern QMS, you’re reducing the risk of human error, streamlining workflows, and freeing up valuable time for employees to focus on more value-adding activities. It also means teams can collaborate in real-time, no matter where they are located, improving communication, and reducing the risk of miscommunications.

Another important feature of a modern QMS is built-in compliance. The ever-shifting regulatory landscape of medical device manufacturing is already tricky to traverse. That’s why a modern QMS should be designed with all the most relevant and up-to-date standards and legislations in mind, including:

• 21 CFR Part 820

• 21 CFR Part 11

• ISO 13485

• ISO 14971

• EU MDR 

Additionally, a modern QMS should be purpose-built and pre-validated. Doing so means companies can be confident that they are meeting all regulatory requirements, without having to worry about the time-consuming and costly process of validating their system. 

Top 6 features of a modern QMS

Let’s take it a step further and examine some of the more concrete features that make a modern QMS so truly powerful for your MedTech organization.

Onboarding and training programs

In order for your team to harness the power of their QMS, they need to hit the ground running–and that’s going to require consistent and ongoing training for employees. 

The modern QMS is purpose-built for the medical device industry by the MedTech vets who lived it. This level of expertise means you can be sure you’re providing instruction and certification that is up-to-date with best practices and processes.

Looking to step up your skill set? Greenlight Guru Academy is the premier learning destination for MedTech professionals, providing courses and certifications developed by top industry leaders.  Click here to learn more!

Traceability and connectivity across the eQMS

The modern eQMS isn’t about reinventing the wheel. It should build off the best concepts and processes of the previous generation of QMS solutions—that means ensuring traceability across all objects, documents, and data in the eQMS throughout the entire product lifecycle. 

As a result, teams are able to make much more informed and prepared decisions, thanks to the single source of truth at the heart of its quality data. 

Data Sharing and Migration Capabilities 

Operational efficiency is one of the biggest outcomes of choosing a modern QMS, as it means reduced manual work associated with transferring, consolidating, duplicating, or entering information across systems. 

It’s critical that team’s establish a connected source of truth to manage multiple processes in a single system, all while being equipped to access and share that data with other tools used across the business.

Ready-to-use & Audit tested SOP templates

No two medical device companies are exactly alike. However, that still doesn’t mean your QMS can’t benefit from proven, industry-standard templates. A modern QMS should come equipped with checklists, gap analysis, and SOP forms that will streamline the implementation of your system and guide your quality activities successfully toward total compliance. 

Out-of-the-box Validation

Improving quality management processes and implementing systems to do so can be easily bogged down by the time, cost, and effort required to validate tools and solutions. A modern QMS partner will help simplify software validation for you. 

This reduces the onset burden of implementation so you can streamline compliance and innovation with pre-validated, purpose-built workflows aligned with industry standards and regulatory requirements.

User-friendly UX

Last but not least, a modern QMS should be designed with the user in mind. That means a simple-to-follow interface that allows you to link items, generate reports, and trace documentation throughout the entire product lifecycle as well as easily link, connect, and transfer critical data within a single source of truth and out to other essential applications in your business.

BONUS RESOURCE: Click here to download your free copy of our QMS Software Vendor Checklist.

Step into the modern age of MedTech with Greenlight Guru’s modern QMS

A modern QMS is more than a daydream—in fact, with Greenlight Guru, it’s a reality. We know that teams are trying to find a way to better access, analyze, and share data from their QMS to make their jobs easier, so we’ve thoughtfully constructed a purpose-built software solution that accomplishes exactly that. 

Greenlight Guru’s QMS software strives to fit and connect into teams’ broader tech stacks and make it simple to get quality and product data out of your eQMS and into your system of record for further analysis or to support internal workflow(s). 

Gone are the days of manual data entry, repetitive work, and a lack of insights. Your MedTech business can now unlock the full power of your QMS data with Greenlight Guru. 

Ready to learn more? Get your free demo of Greenlight Guru →