Connected Health Cluster workshop: Medical Device Regulation
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?
9:30-10:00 Welcome Coffee, registration
10:00-11:15 Medical Device Regulation: What are changes in reality?
speaker 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
Fee: Free of charge for CHC and Tehnopol partners. Others 50,00 EUR + VAT
Target group: Connected Health Cluster members, also all other software developers who provide software solutions to medical device manufacturers. Registration is here. Please register before 25.01.2019. More information Piret.firstname.lastname@example.org