Connected Health Cluster is organizing a\u00a0Medical Device Regulation\u00a0workshop\u00a0 on the 31st of January at 10:00-13:00.<\/p>\n
The seminar will answer the questions:<\/p>\n
What is a medical device? How to get medical devices through regulatory audits? What does the new MDR require?
\nWhat is an ISO 13485 compliant Quality Management System and who needs it?
\nWho is required to have ISO 14971 compliant risk management and IEC 62304 compliant software development in place?
\nHow to kickstart regulatory compliance with Jira and Confluence add-ons?
\nAgenda:<\/p>\n
9:30-10:00 Welcome Coffee, registration<\/p>\n
10:00-11:15 Medical Device Regulation: What are changes in reality?<\/p>\n
speaker Mr. Jani Hopia, Senior Regulatory Specialist from Kasve Ltd<\/p>\n
11:15-11:30 Coffee and networking<\/p>\n
11:30-12:45 Medical Device Regulatory Compliance on Jira & Confluence with SoftComply, speaker Mr. Margus Nael, Co-Founder & CTO of SoftComply<\/p>\n
Place: Tallinn Science Park Tehnopol, Teaduspargi 6\/1, seminar room Merkuur<\/p>\n
Language: English<\/p>\n
Fee: Free of charge for CHC and Tehnopol partners. Others 50,00 EUR + VAT<\/p>\n
Target group: Connected Health Cluster members, also all other software developers who provide software solutions to medical device manufacturers. Registration is\u00a0here.\u00a0Please register\u00a0before\u00a025.01.2019.\u00a0More information\u00a0Piret.hirv@tehnopol.ee<\/a><\/p>\n