AI/ML Innovations’ Tech2Heal Starts Medical Device ISO 13485 Certification Process

  • Hannah
  • June 22, 2022
  • Comments Off on AI/ML Innovations’ Tech2Heal Starts Medical Device ISO 13485 Certification Process

TORONTO, ON / ACCESSWIRE / June 22, 2022 / AI/ML Innovations Inc. (CSE:AIML)(OTCQB:AIMLF)(FWB:42FB), a company committed to acquiring and advancing Artificial Intelligence/Machine Learning technologies that address urgent societal needs, is pleased to announce that its minority-owned subsidiary, Tech2Heal SAS, has reported that it is undertaking the certification of its products and services in accordance with the internationally agreed standard for medical devices: ISO 13485:2016.

Tech2Heal is committed to guaranteeing the safety and quality of the digital health products and services it produces, from design to recycling. ISO 13485:2016 sets out the requirements for a quality management system whereby an organization must demonstrate its ability to consistently provide medical devices and related services that meet customer and applicable regulatory standards.

“We take our commitment to providing the best-in-class products and services extremely seriously. Safety and quality cannot be subjective. Our customers will have the peace of mind in knowing that our products have met and surpassed the exacting standards of ISO 13485,” said Fabrice Pakin, CEO of Tech2Heal. “An added benefit to this ISO certification is that it will also aid in our garnering the coveted “CE” marking on Tech2Heal products, in part by allowing internal self-certifications governed by the ISO procedures in place”.