Manufacturing

Made by us. Inspected by the FDA.

Every Q-Pad Kit is assembled in an ISO Class 8 cleanroom in our own facility in Menlo Park, California. It is registered with the FDA, runs under an ISO 13485-compliant quality system and was inspected by the FDA in August 2026.

Qvin team members in cleanroom gowns assembling Q-Pad Kits in Menlo Park

ISO 8Cleanroom class
200,000Kits a year, capacity
3 yearsKit shelf life
3023949424FDA registration

From raw materials to released kit

From organic cotton to a kit at the door.

Custom pads, made in Italy
Organic cotton, made for us by a qualified, FDA-registered supplier.
Kitted by our own team
Q-Pads, Q-Strip Container, instructions and return mailer, put together by us.
Traceability in our own ERP
Our custom ERP records every component lot, kit and release.
Released for its study
Labeled for its study and lab, straight from the order.

Q-Pads moving along the Qvin production line

Racks of finished kits inside the Qvin cleanroom

Finished Q-Pad Kits, Q-Strip Containers and instruction cards from the Qvin production line

Process and compliance

Cleared, registered, traceable.

FDA 510(k)K231465 Q-Pad Kit and Q-Pad A1c Test.
FDARegistered facility Registration 3023949424. Inspected by the FDA in August 2026.
ISO 13485Quality managementA compliant quality system for medical device design and manufacture.
ISO 14971Risk managementHazards traced into our software.
CE and UKCAMarked Q-Pad Kit, as a collection kit.
Quality systemDesign controls and CAPAMade under the FDA’s quality system requirements for medical devices.
SuppliersQualified and inspectedComponents from qualified suppliers, with incoming materials inspected before use.
TraceabilityLot by lotFrom raw material to finished kit, with controlled changes and controlled release.
After releasePost-market surveillanceWhat we learn in the field feeds back into design and production.