Medical software regulation and compliance (EU) – training, REGISTRATION DEADLINE EXTENDED
Date and time: Helsinki 24.5.2018 at 8:30-16:30
Venue: Tapahtumatalo Bank
Aim: To update the status of the regulatory requirements of medical SW according to MDR/745. To learn about best ways how to utilize IEC 62304 and IEC 82304-1 in practice for compliance (EU). Training covers software incorporated in device (medical device SW) and software that are devices in themselves (SW as medical device). During the training day recent challenges are discussed – like cloud based services and cybersecurity.
Target group: Prioritized especially for medical device industry (manufacturer, product company). Also for medical device research projects (like “Tutli”) . This training day is targeted to software or regulatory affairs professionals who work with theme in practice or are leading these activities at manufacturer / product company.
Instructor: Robert Ginsberg, QAdvis AB. Robert has 30+ years of experience of software development, and the entire chain for product development, Agile, Lean and quality assurance in Medtech environments. He has implemented modern software techniques and methods at several companies. He is often engaged to conduct product and software risk analyses, improve way of working and find and efficient level of compliance.
More info and registration
NOTE: There is some extra space (8-10 attendees) possible at the venue so we extend the registration period until 11.5.2018.
+358 40 5595 726