As you know, designing a new medical device can be exhilarating. However, if you get caught up in the excitement and fail to properly document your steps, your organization could be in for major headaches.
Recently, one organization was cited in a warning letter from the Food and Drug Administration (FDA) for failure to file a 510(k) clearance. It turns out that engineers made significant changes to their acute care system (IACS) M540 that could have impacted the device's safety and effectiveness. Moreover, the organization was cited for incomplete documentation.
Don't let something like this happen to your organization. With these five design controls for medical devices, you will be able to document insights that guide your design team to profound and profitable discoveries—all while keeping your organization FDA compliant.
Design Controls for a Medical Device: 5 Expert Tips
In some cases, design controls might feel like a burden or an unnecessary hassle. However, these controls are put in place to help your business. Additionally, you can maintain a clear view of every stage along the way with proper documentation.
The first step in developing a new medical device is to establish a quality system. This system outlines specific processes and procedures your organization will follow from start to finish.
As such, design controls are a vital part of the quality system that you create, implement, and manage. To kickstart your own medical device development process, follow these five expert design control tips.
1. Master Traceability
A traceability matrix gives you the big picture view of product development from start to finish. It’s typical for traceability tasks to take hundreds of hours per project per year. Using software that was created to meet the unique needs of a medical device company saves time and keeps you organized.
Tools like Google Docs or Excel can be used to track product development, but you’ll soon find that they take way too long to update. However, enterprise quality management software (eQMS) solutions like Qualio make traceability tracking a breeze.
With the right platform in place, you’ll be able to see every step of the product development process via fully integrated, closed-loop quality processes. Our software makes it simple to keep all your key stakeholders informed of every action taken on your project.
2. Maintain Flexibility
Flexibility is an essential part of the design process. You will likely make changes from your initial design several times throughout the product development lifecycle. You will also need to be able to adapt to changes quickly without too much hassle. Documents should be kept up to date as changes are made.
Not keeping track of the changes you make leads to mistakes that could result in costly recalls or FDA audits. So, don’t let bad ideas slip into your final design because you didn’t take the time to document your progress along the way.
Qualio gives you complete control over all your documents. Our secure, cloud-based eQMS platform lets you make changes to documents in real-time so that you can maintain flexibility. Qualio enables you to you create, review, and approve documents effortlessly. You can also use built-in templates to create documents much faster.
3. Manage Risk
Risk management should be incorporated into your medical device development processes from the beginning. Make sure you review ISO 14971 carefully and that your tactics match up with the guidelines.
Design controls should be integrated with risk management, and you’ll need to demonstrate that your medical device is safe for use. Your design needs to address the needs of its users, meet or exceed performance criteria and applicable standards, and be designed to meet requirements and design inputs.
Qualio helps you build better products and keeps your business running smoothly by helping you maintain ISO 14971 compliance. Your eQMS system should have a few key features to help you stay compliant.
RELATED READING: Is Your eQMS Built for ISO 14971 Risk Management Compliance?
4. Review Meticulously
Design reviews are a crucial part of the development process of your medical device project. Bring the whole team together periodically and review the progress that has been made to date.
Your team needs to review and agree to all the different aspects of your project, including:
- User needs: how patients are going to use your medical device and what problems it will solve for them
- Design inputs: the action plan you come up with to meet the needs of patients who use your device
- Design outputs: all of the device components, material requirements, testing protocols, and inspection procedures needed to manufacture your device
- Design verification: proof that your device does what it’s supposed to do
Design reviews should take place after user needs have been drafted, design inputs are established, design outputs are established, the design has passed the verification process—and before going into production.
5. Mark Progress Early
Don’t wait too long to start documenting your progress.
You might think it’ll be okay to come back and do it later after the work is completed. But how likely are you to actually do that? On the off chance that you do come back to it later, how likely are you to remember every little thing that you did?
Don’t get caught in the trap of procrastination that forces you to play catch-up.
Maintain meticulous records and improve the overall quality of your finished product by tracking what works and what doesn’t. The FDA requires you to keep detailed documentation of every step in the development of your new medical device, so don’t cut corners. Qualio makes this easy with several features designed to help you stay compliant with the FDA and document every action that was taken during the development of your medical device.
Master Design Control for Medical Devices
As you know, documentation is at the core of effective quality management. As a medical device manufacturer, you need to carefully and thoroughly document quality by creating a quality manual, quality strategy, quality management plan, standard operating procedures, and detailed records of quality activities.
Qualio’s eQMS is the best cloud-based quality management solution for medical device manufacturers with up to 500 employees. Our software offers unparalleled document management capabilities for fast-growing life science organizations and was built specifically in accordance with FDA 820 and ISO 13485.