Myant X provides technical and regulatory support to assist in developing and implementing Textile Computing™ technologies that comply with established field of use standards/specifications and international laws/guidelines. We work with clients across the development cycle, following the Technology Readiness and Manufacturing Readiness models. With our expertise in regulatory compliance for Textile Computing™ technology, we can provide creative and practical solutions to aid clients in achieving their objectives.
Verification & Validation
We assess the Textile Computing™ technology feasibility and efficacy by conducting investigations into the accuracy and reliability of the systems functionality against design requirements. In a multi-step process, we design and conduct early-stage individual component tests as well as late-stage full spectrum integrative system tests. Our process also reveals comparable performance between the Textile Computing™ technologies and conventional systems.
Certification Preparedness
Myant X adheres to strict national and international quality management and regulatory requirements. We ensure that the regulatory strategies are employed in the technology development, which can satisfy regulators for offerings intended for sale and use in Canada, the USA, and abroad. Where needed we can help transform Textile Computing™ technologies to become digital health products where clinical decision making is done efficiently, in conformance with all relevant regulatory authority expectations, and with capabilities to seamlessly integrate with electronic medical records and other digital health products.
Clinical Sciences
The primary utility of the Textile Computing™ platform is for the users who wear and interact with these smart textile interfaces. It is therefore necessary for the interpretations and determinations of this system to be meaningful, in a clinical manner. The captured data can provide meaningful inputs to support decision making, such as diagnostics, prognosis, risk assessment, pattern monitoring and the like, that could have impacts on an individual’s well-being and health outcomes. Through application of scientific methods and studies, evidence-based clinical information is generated that can demonstrate the efficacy and safety of the Textile Computing™ platform for different indications. The need to strike a balance between the feasibility and usability of smart textiles, as an everyday interface, that can make medically relevant and reliable assessments is the ultimate impression of the Textile Computing™ platform
