Software and Digital Health under EU MDR
September 16, 2020 | Webcast
Even companies that are successfully managing other aspects of EU MDR still wrestle with the challenges of software. Most software currently in Class I will be upclassified, requiring the establishment of a certified quality system and notified body involvement. There is confusion about current and evolving device and system standards and guidances and their relationship to the new regulatory requirements, and significant ambiguity about emerging technologies, cybersecurity, data privacy, interoperability, and risk management.