ISO 13485: Our Commitment to Excellence

Commitment to Quality
A solid commitment to quality is the hallmark of the Passy Muir philosophy that is continually integrated into our products and services. “Passy Perfect” is the mandate from our Founder Patricia Passy that we honor each day by providing highly reliable, quality products that assures the patient the best opportunity for clear, uninterrupted speech and the added clinical benefits of a closed position “No Leak” design. Each valve is manufactured and tested to exceed the highest industry standards. Only the best quality valves may bear the Passy-Muir® trademark symbol.

We have dedicated significant resources to the continued development of diagnostic equipment specifically designed to assess speaking valve performance. We are able to use this state-of-the-art technology to evaluate, test and continually improve Passy-Muir® Valve designs and to further our understanding of the needs of this specialized patient population.

ISO and CE Mark
As part of our quality commitment, Passy Muir maintains the CE Marking of Conformance and ISO Certification (NSAI) to ISO 13485:2016. Meeting the requirements of these internationally recognized standards ensures that our quality management system has proven to be effective, up-to-date and robust.

In achieving compliance with the ISO 13485:2016 standard requirements we chose NSAI, a global leader in testing, inspection and certification. NSAI delivers high quality services to help companies meet the growing challenges of quality, safety, environmental protection and social responsibility. NSAI reviews our management system and provides certification to the standard as an independent third-party specialist. This provides our customers with independent assurance that our commitment to quality permeates everything we do, and can truly be “Passy Perfect” in honor of our founders David Muir and Patricia Passy.

Quality Testing and Standards
All Passy Muir products are produced according to FDA guidelines in a cleanroom facility, using only certified medical grade, non-latex materials. They are tested by an independent biomedical laboratory for tissue compatibility and analyzed to ensure material compliance. Every valve undergoes visual and microscopic inspection at the time of manufacture and must pass our exacting proprietary testing systems before leaving production.

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