- Why Us
The FDA’s Quality System Regulation (QSR) and ISO 13485:2016 both lay out requirements for a medical device manufacturer’s QMS. (The two will soon be harmonized, but that’s another story).
However, the way you carry out those requirements—in other words, the QMS tools you use to meet the requirements—aren’t specified in the QSR or ISO 13485. It’s entirely possible to manage, say, your CAPAs, on a spreadsheet.
The question is, should you?
In my experience, there are a wide range of activities within your QMS that should be managed with purpose-built tools rather than paper or generic software tools.
So, I’ve put together a list of the seven most important QMS tools that any good quality management solution should provide for you (plus four tools outside your QMS that should be MedTech-specific).
Risk management is integral to every MedTech company.
Medical device companies are subject to the requirements of ISO 14971:2019, even in the US. I know some people may be saying, “Hey, that’s not technically true,” but remember, FDA is harmonizing the QSR with ISO 13485:2016. And ISO 13485:2016 references ISO 14971 when it comes to risk management.
So, yes, any risk management software you’re using in your QMS should be capable of aligning with ISO 14971:2019 out of the box. It should also be able to cover your risk management needs throughout the entire lifecycle of your product—whether you’re assessing risk for the first time or managing risk alongside your post-market surveillance activities.
What would that look like, you ask? Probably a lot like Risk Solutions, Greenlight Guru’s first-of-its-kind complete risk management software.
I’ve seen design controls managed on spreadsheets before, and I hope I never have to see that again. If you’re using spreadsheets or other general-purpose QMS tools to manage your design controls, you should expect to dedicate at least one full-time employee to that job.
That’s because your design controls are really a traceability matrix. And when you update your design (which will happen often throughout the development process), you’ll have to manually ensure that all those little spreadsheet cells are changed and reflect the most recent revision.
Or you can get a QMS software solution with purpose-built, collaborative design controls software that ensures changes are reflected throughout your quality management system and lets you generate a design history file (DHF) with a single click.
Which, by the way, is exactly what we built our Design Control software to do—document, track, and trace all aspects of your design control process.
The QMS tools for document management are imperative for MedTech companies, given the stringent regulations outlined in 21 CFR Part 820.40, known as Document Controls. This sets the standard for document approval, distribution, and modifications. Similarly, ISO 13485:2016 delves into this in Section 4.24, emphasizing Control of documents.
In a nutshell, any document, whether new or revised, must be reviewed and approved before it is issued. That review will also require a date and signature by the approver. And if you’re using electronic signatures, you’ll also need to be in compliance with 21 CFR Part 11.
With all the documentation that MedTech companies generate, manually managing all your documents and signatures quickly becomes an enormous amount of work. This is where two essential QMS tools come into play: document management and change management. Notably, Greenlight Guru offers these both as dedicated workflows, seamlessly integrating with your quality management system, ensuring you remain compliant with both Part 820 and Part 11.
Every medical device also needs a bill of materials (BOM). It’s the ingredient list for your medical device. And because products evolve over time (trust me, they all do), your BOM will also change at some point.
All it takes is a change to one of your parts once the device is on the production floor. You’ll need a way to quickly and easily see what’s in your BOM, change it to ensure that it reflects the most recent update to your product, and connect it to the rest of your QMS (like a design output within your design controls). I’m not sure if there’s an excel formula for that, but I really doubt it.
It’s easiest to simply have a QMS tool that allows you to build and manage multi-level BOMs within a connected QMS ecosystem. And because that would be easiest, we built our Products workspace to create a seamless flow from your DHF to your product development process, all while meeting the requirements of ISO 13485.
CAPA, CAPA, CAPA. The number one reason for FDA 483s for as long as any of us can remember.
Getting your CAPA management right isn’t just about avoiding FDA findings, however. It’s really about maintaining the overall health of your QMS tool. If CAPAs are languishing for months or even years because there isn’t a system in place for tracking and investigating them properly, that’s not a great sign for your organization overall.
Any QMS tool worth its salt should have a strong CAPA management software in place that helps you resolve your investigations in a timely and compliant manner.
CAPA may be number one for FDA findings, but complaints are up there as well. You absolutely need a QMS tool capable of capturing customer feedback about your products and ensuring that feedback gets funneled through the proper channels.
In some cases, complaints and other feedback will inform the design of your product. For instance, a series of similar customer complaints may identify an issue with the product that can only be fixed through a design change.
But even if it doesn’t lead to a design change, it’s important to capture customer feedback, which may go on to inform your risk management. Maybe initial feedback leads you to consider the threshold at which complaints would drive a design change.
And let’s not forget that you are legally required to submit serious complaints regarding adverse events and product problems according to FDA’s Medical Device Reporting (MDR) requirements.
Your ability to collect customer feedback and get it to the right people within your organization is paramount to building safe and effective medical devices—and the best QMS tools make that possible.
Unfortunately, many QMS tools lack essential traceability, visibility, and access to current information, preventing teams from seeing the big picture and understanding the impact of customer complaints.
With Greenlight Guru, you get connected and streamlined customer complaint management. Our purpose-built QMS software allows you to capture feedback and complaints in the same system as your product’s design, management, and risk with interlinking capabilities so you can see everything impacted by customer feedback.
What kind of difference does Greenlight Guru’s QMS software actually make to medical device companies? One of our customers said it best,
With Greenlight Guru, we have been able to solve training gaps, on-time completion of customer complaints and non-conformances, and change orders. Prior to Greenlight, we had complaints that sat uncompleted for over a year. Now with GG we’re able to close them in less than 30 days.
Training management is a constant battle for most medical device companies. Not only do you need to make sure that people are completing required training, you need to have it documented and ready to show FDA inspectors or auditors who come knocking.
QMS tools that are missing a training management process force the user to manually ensure that all of this is happening—following up with people, updating records, pulling documents—and it can quickly become a full-time job. At the very least it slows you down and opens you up to potential findings during an audit.
The best QMS tools come equipped with a training management solution that tracks this for you, sending out reminders to folks who need training and keeping everything tidily documented for FDA or auditors.
I’ll cut to the chase: if you’re looking for a purpose-built quality management solution that has all these QMS tools and more (a lot more), then look no further than Greenlight Guru. We built our QMS solution specifically for medical device companies, which is why our quality management software makes managing all the different parts of your QMS so incredibly simple.
If that sounds like something your MedTech company could benefit from, then get a free demo of Greenlight Guru and see what a modern, purpose-built quality management system can do for your business.
While having a suite of QMS tools at your disposal is a great way to produce and maintain the safest, most effective medical devices possible, your quality management system isn’t the only thing that will help you manage your people, processes, and technology.
Here are four of our favorite MedTech tools that will make life a lot easier for you:
When it comes to gathering clinical data—throughout the entire lifecycle of your device—you’re going to want an electronic data capture (EDC) solution that’s built specifically for MedTech.
Greenlight Guru Clinical moves you away from paper and puts you in the driving seat of a modern, MedTech specific EDC solution that’s built to handle clinical data from trials, to surveys, to so much more.
Remember, just because you don’t need a premarket clinical trial, that doesn’t mean you’ll never need to collect clinical data on your device. Post-market surveillance requirements, especially in the EU, make it imperative for you to have a great EDC solution to work with.
Managing Unique Device Identification (UDI) information might not be the most exciting part of bringing a medical device to market, but it is a necessary one. Countries around the world, including the US and EU member states, have regulatory requirements for identifying each specific product with a static device identifier.
UDI can get complicated quickly, and it may be in your best interest to have a partner like Reed Tech to help with your product data management requirements under UDI regulations around the world.
Did I mention we like tools built specifically for MedTech companies around here? Well, we do, which is why I’d also recommend Galen Data’s cloud computing service. It’s built specifically for medical device companies, which means it was developed under an ISO 1385 certified QMS and offers full regulatory audit support for FDA, EC, and Health Canada.
EU MDR requires medical device manufacturers to perform a clinical evaluation of their medical devices, which includes a literature review for your device and the “current knowledge/state of the art.”
Nested Knowledge is a software tool for systematic literature review and meta-analysis, which can quickly help you find existing reviews, add individual studies to your review, and help you connect concepts across the literature. It’s a massive time saver and a pretty cool tool to boot.
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...