Every device we make is designed, built and supported under one quality management system. This page describes that system, how we talk about regulatory status, and what happens when something goes wrong.

Quality policy

We design and manufacture devices that do what their labeling says, for as long as their labeling says, and we tell customers promptly and plainly when they do not. We measure ourselves on complaints, returns, corrective actions and the time it takes to close them, and we review those measures every month at leadership level.

Quality management system

Our quality management system is certified to ISO 13485 for the design, manufacture, servicing and distribution of connected medical devices and associated software, at both Minnesota sites. It is also designed to meet the US quality system requirements for medical devices.

  • Risk management follows ISO 14971 throughout each device's life, from concept to end of support.
  • Software is developed under IEC 62304. Lattice OS 4 has been independently assessed for Class C software.
  • Usability engineering follows IEC 62366-1, including formative and summative studies with real users.
  • Electrical safety and electromagnetic compatibility are tested to the IEC 60601 series, much of it in our own semi-anechoic chamber.
  • Cybersecurity is managed under a lifecycle aligned to IEC 81001-5-1.

Regulatory status of our devices

Our devices are marketed in the United States under clearances from the US Food and Drug Administration, in Canada under Health Canada licenses, and in the EU and UK under the applicable medical device regulations. Regulatory status differs by device, by model and by market.

The authoritative statement of each device's regulatory status, intended use, indications and contraindications is its labeling and instructions for use, not this website. Clearance and license details for a specific device are available from our regulatory team.

Axon Sense 3 has completed bench validation and is in limited release to existing customers in the United States. It is not yet available in other markets.

Post-market surveillance

We monitor the performance of every device in the field through complaints, returns, failure analysis and the fleet data Formcloud provides about device health. Trends are reviewed monthly. When a problem requires customer action, we issue a notice and publish it on our recalls and advisories page, after contacting affected customers directly.

Reporting a problem with a device

If a Nexaform device may have caused or contributed to harm to a patient or user, call product support on +1 (612) 555-0199, at any hour. Every such call opens a complaint record that our quality team reviews. You may also report directly to your national regulator.

For anything else, including documentation requests, write to quality@nexaformlabs.com.

Documents for customers

Customers can request our ISO 13485 certificate, declarations of conformity, device labeling, and the summaries our validation teams need. Most are in the customer portal; the rest come from the regulatory team.

Nexaform Labs is a fictional company and this page is demonstration content. It is not a real legal document and creates no obligations.