Challenges NanoDx™ needed a QMS to comply with various medical device regulations. They also needed a single source of truth for product and quality information to support their compliance, streamline document management, and keep everyone in sync.

About the Company

NanoDx™, Inc. develops innovative, point-of-care, in-vitro diagnostic solutions to improve patient outcomes while reducing healthcare costs. The company’s NanoDx™ Tbit™ System is a first-of-its-kind device, employing patented nanowire biosensor technology to deliver accurate test results in just minutes. The NanoDx™ System is highly versatile, performing a range of tests for applications including traumatic brain injury (TBI) and COVID-19.



To be a leader in point-of-care diagnostics, delivering novel solutions for unmet needs to help people worldwide live healthier, safer, and happier lives

Best Thing About Arena

Links items, BOMs, designs, quality records, and changes in a single source of truth for enhanced visibility and efficiency

Bottom Line Impact

Significantly reduces the time spent searching for information and processing engineering changes

Business Challenges

As a startup, NanoDx™ is in the early clinical trial stages of product development. To comply with ISO 13485, FDA, and EU IVDR medical device regulations, they must maintain a quality management system (QMS) with extensive product and quality documentation.

Initially, NanoDx™ managed their QMS via paper and spreadsheets. Records were updated manually and stored in filing cabinets. Engineering change orders (ECOs) and electronic signatures were managed through DocuSign. With teams distributed across multiple locations, it was difficult for everyone to locate files and keep track of the latest revisions. This often led to confusion and duplication of information. Because the organization did not have a single source of truth to process engineering changes, everyone was not aligned on the latest product release. “We accumulated a tremendous backlog of open change orders due to our manual processes and fragmented systems,” stated Angie Swanson, Lead Quality Engineer at NanoDx™. “The lack of automation and transparency slowed us down.”

Ultimately, NanoDx™ set out to find a cloud-based QMS solution that could support their compliance requirements, streamline the management of their product and quality documentation, and keep everyone in sync.

The Solution

After evaluating several enterprise solutions, NanoDx™ chose Arena QMS.

"We like the fact that Arena is cost-effective and highly configurable. We can customize the system to accommodate our unique workflows. Arena’s automated change management system enables our teams to share documents seamlessly and keep track of revisions."

–Angie Swanson, Lead Quality Engineer, NanoDx™, Inc.


Arena QMS centralizes all product and quality information in a single cloud-native platform, enabling NanoDx™’s distributed teams to quickly find files and compile accurate information. Since engineering changes are connected to items, bills of materials (BOMs), and drawings, NanoDx™ can readily identify bottlenecks in the ECO process. Automated revision controls ensure that everyone is always accessing the latest document revisions and working from the correct product release.

With their complete product history easily accessible in Arena, NanoDx™ gains full traceability and control over their processes to streamline ISO, FDA, and EU IVDR compliance.


Key Benefits

Enhancing operational efficiencies

Since deploying Arena QMS, NanoDx™ employees have fully embraced the system. Each employee has access to certain functionality based on their specific role and user-defined access controls.

Cross-functional teams take advantage of Arena’s intelligent BOM and item management capabilities to expedite processes and minimize design errors:

  • Marketing maintains product labeling and instructions for use (IFUs) within Arena.
  • The software team loads requirements, specifications, and software iterations into the system. They have the flexibility to customize software release numbers according to their specific naming convention.
  • Engineers load BOMs and associated drawings for printed circuit board designs.

By participating in Arena’s ECO process, these departments maintain visibility on product changes. Everyone can efficiently share and review documents and submit electronic approvals to meet FDA 21 CFR Part 11 requirements for electronic signatures.

Arena Projects allows NanoDx™ to manage the design history file (DHF) comprised of design inputs, outputs, etc. A project stage is assigned to each element of the DHF to track its status. Because all the product’s top-level assemblies and labeling link directly to the project, stakeholders can easily collaborate on open action items and work toward a successful completion.

Arena Training enables the organization to efficiently manage employee training and demonstrate compliance. Electronic signatures and time stamps are applied to each record once training is executed. In turn, NanoDx™ can compile complete training records for future audits. They are also configuring the Arena Training module to track equipment calibrations and preventative maintenance.

Another benefit for NanoDx™ is Arena Validate. It reduces the financial and administrative burden of software validation by providing a comprehensive set of validation documentation and reports to ensure FDA compliance.

NanoDx™ finds inventive ways to further streamline their processes using Arena’s advanced functionality and flexible platform. In lieu of spreadsheets, they’re developing an interface that can trigger Arena to create serial numbers and assign the proper values (i.e., manufacture and expiration dates, lot number, and serial number) through their label database. Since this information is tied to the assembly and revision controls are applied, they can ensure that product labels are always accurate.

As the company ramps up production and expands their use of supplier items in Arena, they plan to get contract manufacturers and other external partners on board with using the system.

Paving the way for commercialization success

With their product and quality information now connected in a single digitized system, NanoDx™ is primed to reach their compliance goals and achieve commercialization success.


"Arena’s connected quality management approach helps us stay on track with meeting our product development milestones. We’re able to gain a snapshot of our progress at any given time with just a few clicks. It’s truly a game-changer!"

–Angie Swanson, Lead Quality Engineer, NanoDx™, Inc.