How to Achieve Medical Device Compliance Fast: Fractyl’s Story
Compliance is critical to medical technology companies — such as Fractyl Health.
Fractyl was founded in late 2010. They are developing the Revita™ duodenal mucosal resurfacing (DMR) system. This is an investigational, minimally invasive, therapeutic clinical procedure. It is designed to address the intestinal cause of insulin resistance and restore metabolic health to Type 2 diabetes patients.
Fractyl takes medical device compliance seriously. It helps them ensure their product is safe for patients to use. But it was a time-consuming, manual process to prove compliance. Fractyl needed a solution that would speed up their time to compliance.
Helix ALM Helped Fractyl…
Achieve CE certification 12 months ahead of schedule.
Get certification for the 2016 version of ISO 13485.
Create a traceability matrix that meets FDA and ISO standards.
Helix ALM helped us go from Word docs to compliance and CE certification in record time.
Why Achieving Medical Device Compliance Is Difficult
Meeting FDA Quality System and ISO regulations is important in the medical device industry.
Fractyl needed to adhere to medical device regulations, including:
- IEC 62304
- ISO 14971
- ISO 13485
- 21 CFR Part 11
Part of the regulations are met using a traceability matrix. This matrix details the inputs (requirements) and outputs (test cases and test runs). It demonstrates to regulatory agencies that requirements have been tested and met (with objective evidence).
But in the beginning, Fractyl managed requirements in Microsoft Word documents. And their issues were kept in Jira, a common bug tracking tool. There was no way to get the traceability — the links between requirements, issues, and tests — that they needed.
Fractyl could have tried to create a traceability matrix using Microsoft Excel. But they would have had to manually document the links for the traceability matrix. When requirement sets got larger, this solution simply wasn’t sustainable.
“But it’s a very manual process to maintain a traceability matrix in Excel,” said Ann Rossi, Senior Software Quality Assurance Manager. “I’ve been there. I’ve done that. And I knew I had to find a better solution.”
She found it with Helix ALM.
How Helix ALM Made Traceability Easy
Now that Fractyl has Helix ALM, creating a traceability matrix for regulatory agencies is easy. That’s because Helix ALM has modules for:
These three modules work together to create the traceability that Fractyl needs for compliance. Creating the links between requirements, issues, and test cases is easy. That means requirements can be traced through testing and bug fixes. And requirements, test cases, and test runs can be quickly pulled into a traceability matrix.
Helix ALM also helps Fractyl maintain compliance in the testing process. Testers can’t start a test run until the test case has been fully approved. And Fractyl gets both the expected and actual results right within test cases and test runs.
Record Times for CE Mark in Medical Device and More
Helix ALM helped Fractyl achieve several compliance certifications in record time, including:
- ISO 13485 (2003 version) in August 2014.
- CE Mark in April 2016 (12 months ahead of schedule).
- ISO 13485 (2016 version) in September 2017.
Achieving compliance is important to ensure patient safety. Fractyl can be confident that the Revita™ DMR System is thoroughly tested to determine procedural safety for patients.
Meet Your Compliance Requirements
Helix ALM helps companies like Fractyl achieve compliance every day. See for yourself how Helix ALM will help your organization accelerate compliance — so you can get your product to market without compromising quality or safety.
Try it free for 30 days, with no obligation.