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? 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
Target group: Connected Health Cluster members, also all other software developers who provide software solutions to medical device manufacturers.
Fee: 50,00 EUR + VAT. Free of charge for CHK and Tehnopol partners.
Registration here. Please register before 25.01.2019. More information Piret.hirv@tehnopol.ee
Language: English
