Navigating ISO 13131: challenges for MedTech manufacturers?
ISO standard 13131 provides a framework for managing telehealth services as part of the medical device environment. It combines the baselines of standards for risk management and medical devices with regulatory requirements derived from the AI (Artificial Intelligence) Act, Data Act and GDPR. Laws/ regulations / guidelines: ISO 13131:2021 ISO 13485:2016 ISO 14971:2019 ISO 31000:2018 […]
Navigating ISO 13131: challenges for MedTech manufacturers? Read More »