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. But it was a time-consuming, manual process to prove compliance. Fractyl needed a solution that would speed up their time to compliance — without compromising product quality or safety.
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 multiple medical device regulations, including:
- IEC 62304
- ISO 14971
- ISO 13485
- 21 CFR Part 11
Parts 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.
Initially, Fractyl managed requirements in Microsoft Word documents. And their issues were kept in Jira, a common bug tracking tool. But there was no direct way to get the traceability — the links between requirements, issues, and tests — that they needed.
Fractyl could have created a traceability matrix using Microsoft Excel, but they would have had to manually document each one of these links. When requirement and testing sets get larger, this patchwork of tools simply isn’t sustainable.
“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 to prove compliance for regulatory agencies is easy. That’s because Helix ALM has integrated 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. Once these links are created, traceability happens automatically in Helix ALM. Requirements can be traced forward through testing and bug fixes. And test results can be traced back to requirements. All requirements, test cases, and test runs can be quickly pulled into a comprehensive traceability matrix.
Helix ALM also helps Fractyl maintain compliance throughout 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)
- CE Mark — 12 months ahead of schedule
- ISO 13485 (2016 version)
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 automate traceability, streamline complex development, and accelerate compliance — so you get your product to market without compromising quality or safety.
Try it free for 30 days, with no obligation.