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.
QAiRA's story continues as product of Kasve Ltd
QAiRA's story continues as product of Kasve Ltd, and thanks to this change, the expertise of Kasve´s QA and RA experts can be used more effectively in QAiRA's development.
Kasve introduces: The QAiRA story
Qaira Ltd is a software company founded by medical device and software professionals.
Medical Device Regulation Workshop 31.1.2019 Tallinn
What is a medical device? How to get medical devices through regulatory audits? What does the new MDR require?