Quality Management Software for Medical Devices: The 8 Essential Requirements
You already know that your current quality management system is hurting your medical device company — but how do you pick the right replacement?
Your medical device quality management software is more than just a computer program tracking things.
- It’s a time-saver for your team.
- It’s a game-changer for your company that can elevate your position in the marketplace.
- It’s a life-saver (literally) for your customers when you can control quality and address problems quickly.
This isn’t a decision that you can make lightly, and it’s important that you do your due diligence.
If you want to become an industry-leading, quality-driven company, you know that your team needs the right tools and support. Moving to a new solution is going to represent a significant investment of time and resources, so you don’t need to make a bad decision.
As an industry-leading quality management software provider for young and growing life sciences companies, we know a thing or two about finding software that’s the right fit for your company at your current growth stage.
Keep reading, and we’ll share some of our insider insights to help you make this crucial decision.
8 Essentials of a Quality Management Software for Medical Devices
- Seamless Process Linking
- Real-Time Collaboration
- Automated Workflows
- Integrated Change Management
- Ease of Use
- Customer Support & Onboarding
At Qualio, we know that quality management software is more than just technology. You need a provider that will take the time to help you decide if they’re the right fit for you and then continue to provide that same game-changing support through implementation and on into daily use.
With a platform that is easy, fast, and scalable, we're the industry-leading quality management software for medical device manufacturers with 5-5oo employees. We know we're not the right option for everyone, but we also know there are some deal-breaking essentials that you shouldn't do without.
Use the list below to dive deep into each of the eight essentials that you need to know about to make the right choice.
Your regulatory bodies don’t consider the size of your company during the pre-submission process for devices. Big or small, they expect you to uphold standards and deliver high-quality, safe devices to the public.
Your enterprise quality management system (eQMS) needs to meet your needs now and grow with you as your company expands.
Initially, you’re going to be looking for features that replace and improve what you do now. These include:
- Document Control
- Risk Management
- Employee Training
As you grow, your needs will grow too.
You will need to manage testing and procedures like CAPA inside your eQMS while streamlining your device submission. You may also be looking for compliant systems that can give you a higher market valuation by providing the ability to easily export data if you’re sold to a larger-market company.
Small and growing companies should prioritize an agile QMS. It will adapt to your processes and procedures while still giving you the framework you need to help keep your company compliant with regulatory bodies.
It should support a process of continual closed-loop quality tracking and give you the ability to measure the results against your goals.
Look for features that enable you to customize and control your processes. These include:
- The ability to document your process and track progress against your overall business objectives.
- Reporting and detailed insights to help continuously improve your quality processes and systems.
- Necessary resources that enable you to run compliant processes and systems and avoid medical device compliance problems.
3. Seamless Process Linking
Your processes define the way you get work done. Initial ideas become prototypes and prototypes become working devices that are released into the market.
Every document is carefully managed. Every test and revision is carefully documented.
The flow your devices go through to move from idea to reality needs to be carefully tracked and seamlessly linked. You don’t want to have any gaps that you can’t account for.
Your eQMS system should provide a way to seamlessly link processes, documents, and policies. It should become a digital living model of your entire organization — from A to Z.
You can benefit greatly from the insights you’ll gain with such a comprehensive overview of your device ecosystem. It will be easy to make iterative quality-driven changes when the need arises.
RELATED READING: How to Shrink the FDA Medical Device Approval Timeline
4. Real-Time Collaboration
Poor communication can lead to a great many costly delays as you work to bring your product to market. One of the biggest avoidable sources of delays is collaboration.
For example, in paper-based systems, your team is forced to follow the paper trail — literally. Documents are created, emailed, read, emailed again, and again, and again.
Revisions are made and painstakingly tracked while collaboration involves:
- Chasing down a string of emails and attachments trying to find the latest version.
- Hunting down a lost file that’s on someone’s desk.
- Scheduling meetings to review documents in person.
When you move to a digital eQMS, you immediately start to notice the time savings once you start using the collaborative features.
- Multiple users can work on a document at the same time and share feedback with each other without having to book a meeting room and block off time.
- Users can be located around the world and still work together in real-time.
- Revision tracking is automatic and past revisions are stored.
- You can ask for feedback and track the progress of your documents as they go through workflows.
- Notifications can be activated that will remind users that they need to take action on a document.
RELATED READING: The Best QMS Software: The Pros and Cons of the 5 Top Options
5. Automated Workflows
FDA and ISO regulations both require you to have workflows established to monitor quality, track complaints, and follow CAPA procedures. Automated quality management workflows can also act as a tool for organizational transparency across all of your processes.
The enhanced visibility that your eQMS provides can give you the opportunity to become a quality-driven company that utilizes closed-loop metrics to eliminate sources of risk and waste.
You can optimize performance and manufacturing while also improving consumer safety and building your brand. Having automated quality workflows is a win-win feature.
6. Integrated Change Management
"Every success story is a tale of constant adaptation, revision, and change." — Richard Branson
Change is inevitable on your path to success, but in a highly regulated industry, change can also be a catalyst that can create failures.
As your company grows, you will need to implement changes and a process for making sure the changes are safe, effective, and optimized for quality. A solid eQMS platform will provide features to help you document and track changes in your documents and processes.
7. Ease of Use
ISO requirements are constantly in flux as the market, consumer behaviors, and software change. The right software provider will understand that you have an important and demanding job to do and will design their software to enable you instead of hinder you.
It will keep up with changes in regulations that could slow you down and implement features to help you stay compliant. Your medical device quality management software will help you save time without a steep learning curve.
Every member of your team needs to be able to use your eQMS well. Keep in mind that you should take your least technologically advanced users into consideration. If you're confident that person can use the platform, you're in good shape.
8. Customer Support & Onboarding
All of the essential features mean nothing if you can’t figure out how to use them or apply them to your specific business and needs.
A great quality management software provider for medical device companies will back their tools with knowledgeable humans that will step in and guide you when you need them.
- They’ll be there with you from the very beginning to help you figure out if the software is a good fit for you.
- They will have a team in place that will help you onboard onto their software. Having skilled implementation specialists there to guide you through setup can significantly reduce the time it takes to get up-to-speed.
- Their support team will be available to answer questions or if you need help with aspects of daily use.
Now, it’s time to find out if Qualio is the right fit for you. If you’re a medical device company with 5-500 employees, we built our platform for you. Just schedule a demo to see why we say that. In just 45 minutes, we can help you narrow down your list of possible software providers, show you the features in action, and answer your questions.