Five things every device has to prove before it carries our name. No exceptions, no product-by-product negotiation.
Nothing carries the MaxMed name until it clears all five. This is the process, not a promise.
Tested against trained clinical observers under the international protocol for its category.
Reviewed and cleared by the U.S. Food and Drug Administration before it reaches a home.
Every device ships with a published tolerance. We state the number, and we test to it.
Every surface that touches skin is tested for biocompatibility to ISO 10993.
Manufactured under a certified medical device quality management system.
Every measuring device is validated against trained clinical observers using the ISO 81060-2 protocol — across arm sizes, ages, and pressure ranges. Passing means the device agrees with a clinician, not with a lab bench.
Devices are cleared by the FDA through the 510(k) pathway before they reach the market. Clearance documentation is available on request.
Every device ships with a stated accuracy. For blood pressure, that is ±3 mmHg for pressure and ±5% for pulse — printed in the manual, not buried in a footnote.
Every surface that touches skin is tested for biocompatibility to ISO 10993. Cuff bladders are latex-free.
Produced under an ISO 13485 medical device quality system, with electrical safety and EMC tested to IEC 60601.
MaxMed is a medical device company built on a simple idea: accuracy shouldn’t be complicated, and clarity shouldn’t be optional.
About MaxMed
