JTECH Medical, a medical device company developing innovative, next-generation therapeutic and evaluation products, is certified to ISO 13485:2016 with MDSAP. JTECH has also received a Device Establishment License to distribute our products throughout Canada, as well as maintaining CE certification on all medical devices we produce.
Commenting on JTECH's Certifications, Chris Neil, President of JTECH Medical, said, "Achieving MDSAP certification is a further endorsement of JTECH's manufacturing capabilities and approach to quality system management. This has enabled us to move forward with the registration and commercialization of our products in Canada. We plan to aggressively promote and market our products in Canada immediately. Being certified to the ISO 13485 standard in our manufacturing facility emphasizes our commitment to maintaining and improving the quality of our products, manufacturing processes and communications with our customers. This commitment and certification allows us to move closer to our goal of providing the highest quality therapeutic and evaluation products."
The ISO standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. The ISO standard provides a tried and tested framework for taking a systematic approach to managing an organization's processes so that it consistently turns out products that satisfy customer expectations and can assure regulatory authorities that JTECH Medical is manufacturing products using a quality management system in its facility.
The ISO 13485:2016 standard is an international reference standard for the evaluation of quality management systems for the medical industry. The standard refers to an organization's structure for managing its processes or activities that transform inputs of resources into a product or service to meet customized objectives, such as satisfying customer quality requirements.
Compliance to ISO standards are certified by third-party audit and registration organizations.