ALM Solution from Perforce Chosen for Medical Device Compliance at Fractyl Laboratories
Fractyl uses Helix ALM to achieve medical compliance with FDA and ISO regulations in record time
MINNEAPOLIS, April 24, 2018 – Perforce Software, a provider of solutions to enterprise teams requiring productivity, visibility, and scale along the development lifecycle, has been selected by Fractyl Laboratories to provide end-to-end ALM for medical device compliance.
Fractyl is a growing medical technology company. They are developing the Revita™ duodenal mucosal resurfacing (DMR) system to treat type 2 diabetes and NAFLD/NASH.
As a medical device manufacturer, Fractyl needs to meet compliance regulations from the FDA and ISO. That’s why they chose Helix ALM for their application lifecycle management solution in 2013.
“Helix ALM helped us go from Word docs to compliance and CE Mark Certification in record time,” said Ann Rossi, Senior Software Quality Assurance Manager at Fractyl.
Helix ALM helps Fractyl create the traceability matrix they need for regulatory agencies. As a result, Fractyl has received several compliance certifications in record time — including a CE Mark 12 months ahead of schedule.
Revita™ DMR System is currently under clinical investigation and is not commercially available.
Fractyl Laboratories is a private medical technology company based in Lexington, Mass. Fractyl is developing Revita DMR, a same-day, minimally invasive procedure to treat two highly prevalent metabolic diseases: type 2 diabetes and NAFLD/NASH. The Revita DMR procedure harnesses breakthrough insights in the role of the duodenum in causing insulin resistance and metabolic diseases. Fractyl’s approach aims to improve the health of patients with metabolic diseases with device-based interventions for patients and healthcare systems. The Revita DMR System received a CE mark in the European Union in April 2016. The Revita DMR System may be available for investigational use in other regions. For more information, visit www.fractyl.com or www.twitter.com/FractylLabs, or www.RevitaTrial.com.
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