Case Study: Bigfoot Biomedical achieves traceable, regulatory-ready medical device development with Intland Software's codeBeamer ALM

Bigfoot Biomedical scales to 80+ users and restores traceability with Intland Software

Bigfoot Biomedical, a medical device startup, faced significant challenges with fragmented development tools that jeopardized regulatory compliance and traceability. Their existing systems produced unreliable document exports and manual workarounds, creating risks for meeting standards like IEC 62304 and FDA requirements. To solve this, they partnered with Intland Software.

Bigfoot Biomedical implemented Intland Software's codeBeamer ALM as a single system of record, configuring it to link all development artifacts. This solution restored automated traceability, simplified reporting, and improved collaboration across their growing team. The results included scaling to over 80 users, enabling continuous integration, and establishing a clear pathway to sustained audit readiness for their critical medical device development.

Bigfoot Biomedical