Noninvasive Medical Technologies, Inc. (NMT), an award-winning company engaged in pioneering highly advanced remote patient monitoring solutions, today announced that it has been awarded ISO 13485 certification of its quality management systems for the design and manufacture of safe and effective medical devices. This certification represents an important step towards securing the ability to market and sell NMT products in the European Union and other ISO member countries.
Globally recognized, ISO 13485 standards are set by the International Organization for Standardization, a Geneva-based worldwide federation comprised of national standard bodies representing 158 of the 195 total countries in the world. ISO works in partnership with international organizations, governments, industry, business and consumer representatives to establish the standards by which best in class service organizations are measured and perform.
Ann McCaughan, NMT's COO and CTO, noted, "We take tremendous pride in the fact that NMT is pioneering highly advanced medical assessment and monitoring devices that are designed and manufactured in accordance with the strictest quality control practices. To demonstrate and confirm this, we underwent an intensive audit designed to ensure that our internal quality control mechanisms and processes, spanning and impacting all areas of our organization, conform to ISO certification standards. Every procedure and protocol - ranging from systems for ensuring business process effectiveness to how we document and maintain all records - was vigorously scrutinized to guarantee compliance."
Continuing, she added, "The award of this independent certification marks yet another crucial milestone in NMT's efforts to achieve global market acceptance and adoption of our revolutionary patient monitoring solutions. Moreover, it helps to support our underpinning mission: to save lives by continually advancing the standard for noninvasive patient monitoring across the care continuum, while maximizing clinical, medical and financial outcomes and promoting scientific innovation."
FDA strengthens AI regulation to ensure patient safety and innovation in healthcare