Medical Device Regulation Workshop

  • 31.01.19
  • 10:00 - 13:00
  • Tehnopol event

Teaduspargi 6/1, room Merkuur

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: Free of charge for CHK and Tehnopol partners. Others 50,00 EUR + VAT

Registration here. Please register before 25.01.2019. More information Piret.hirv@tehnopol.ee

Language: English

See also Facebook event here.

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