Connected Health Cluster is organizing a Medical Device Regulation workshop on the 31st of January at 10:00 -13:00. The seminar will answer the questions: What is a medical device? How to get medical devices through regulatory audits? What does the new MDR require? What is an ISO 13485 compliant Quality Management System and who needs it? Who is required to have ISO 14971 compliant risk management and IEC 62304 compliant software development in place? How to kickstart regulatory compliance with Jira and Confluence add-ons?
Agenda: 9:30 -10:00 Welcome Coffee, registration 10:00 -11:15 Medical Device Regulation: What are changes in reality? Apeaker Mr. Jani Hopia, Senior Regulatory Specialist from Kasve Ltd 11:15 -11:30 Coffee and networking 11:30 -12:45 Medical Device Regulatory Compliance on Jira & Confluence with SoftComply, speaker Mr. Margus Nael, Co-Founder & CTO of SoftComply Place: Tallinn Science Park Tehnopol, Teaduspargi 6/1, seminar room Merkuur Language: English
ECHAlliance members wishing to attend should contact firstname.lastname@example.org