Medical devices save lives. The sooner you can get your medical device out to the market, the sooner it can help people.
But before you can do that, you need to achieve medical device compliance.
Why Is Medical Device Compliance So Important?
Medical device compliance is important to the success of every medical device manufacturer. Failing to achieve compliance will compromise your device’s future.
Here are three reasons why you need to prioritize medical device compliance.
1. Ensure Medical Device Safety for Patients.
Patients expect medical devices to be safe. Using medical devices should improve their health and even save their lives.
That’s why proving medical device compliance is important. It guarantees patients that the device they are using is, in fact, safe.
And the ultimate goal of developing a medical device is to help patients. If your device isn’t safe, you’ll risk patients getting hurt.
By ensuring medical device safety, you’ll make it easier to…
2. Get Medical Device Approval From Regulatory Bodies.
The medical device industry is heavily regulated.
Regulatory bodies — including the FDA — have compliance regulations to make sure medical devices are safe to use. These regulatory bodies also put an emphasis on creating quality products.
After all, producing quality medical devices is in everyone’s best interest. That’s why the FDA launched their Case for Quality program in 2011 to help manufacturers produce high-quality products. And that’s why ISO 13485 is focused on medical device quality.
Getting their stamps of approval is critical to sharing your device with the world.
If you’re manufacturing a device for use in the U.S., you’ll need to prove FDA compliance. If you’re manufacturing it for international use, you’ll need to prove ISO compliance. In most cases, medical device manufacturers need to adhere to both FDA and ISO regulations.
The stakes are high on medical device approval. Without approval, you’ll face penalties. And if you stay noncompliant, you’ll compromise your medical device’s ability to reach its market.
3. Make Medical Device Audits Go Smoothly.
You could be audited at any time. For instance, the FDA recommends quality audits happen every 12 months or less (for compliance with 21 CFR 820.22). So, you always need to be prepared for a medical device audit.
If you’ve met compliance regulations (and you have a well-documented traceability matrix), you’ll be prepared for an audit.
What happens if you don’t pass an audit? The penalties are high:
- You’ll need to respond to the regulatory body, e.g. by filling out a 483 form for the FDA.
- You’ll have to pay to fix the problem — and you might be facing fines.
- Your reputation could suffer, especially if you receive a warning letter or your device is recalled.
How to Achieve Medical Device Compliance
You know achieving medical device compliance is important. But how do you actually do it?
For starters, you need traceability — especially for your requirements and test cases. Creating a traceability matrix is an effective way to prove compliance to regulatory agencies.
Tracing requirements and testing from the get-go makes it easy to create a traceability matrix. Storing requirements in Microsoft Word makes it difficult to trace requirements through development. And that often leads to a manual process of creating a traceability matrix in Microsoft Excel.
There are other measures that can help you with compliance, too. Detecting errors early in medical device development can help you save on costs in the long-term.
One way to do this is to do medical device testing early and often. This will help you make sure you’re meeting requirements as you develop your product.
How Fractyl Achieved Medical Device Compliance in Record Time
One medical device developer, Fractyl, was able to create a traceability matrix and prove compliance in record time. That’s because they chose a tool (Helix ALM) that helped them trace requirements, issues, and tests through the development process.