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
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.
Kasve is visting Slush! Come and meet us at the demo booth area. We will be showcasing our QAiRA regulatory compliance toolkit that assists medical-device and health-tech companies with all their regulatory compliance tasks.
Come and meet us at Slush!
We have a demo booth at Slush on Thursday 17th of November and we will be on-site also on Friday the 18th! Our team Mikko, Ilkka and Elli are waiting to meet you all.
Kuopio Region Goes Virtual: a new virtual way to get business partners from around the world
Kuopio Region goes Virtual program's info and networking event gathered companies interested in exporting to Kasve´s office in 11.10.2022 to hear what is this new virtual matchmaking to network business partners from across the world.