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?
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

Place: Tallinn Science Park Tehnopol, Teaduspargi 6/1, seminar room Merkuur

Language: English

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.hirv@tehnopol.ee

See also Facebook event here.