This two-day seminar is designed for English speaking professionals that have to navigate and comply with the complex medical devices regulations and approval processes. The goals of the seminar are:
The seminar is a best-of Johner Institute seminars that has been compiled for an English-speaking audience.
Time | Topic |
Day 1: Focus Regulatory Framework, IEC 62304 | |
09:00 | Welcome, Expectations |
09:20 | Introduction |
09:45 | Regulatory Landscape, Directives (e.g. MDD), Regulations (e.g. MDR), Standards |
10:30 | Coffee Break |
10:45 | Software as a Medical Device: Classifications, Examples, Artificial Intelligence |
11:15 | Conformity Assessment in Europe and Market Approval in the US (focus: Software) |
11:45 | Overview IEC 62304, Requirements Specification (1/2) |
12:30 | Lunch Break |
13:30 | Overview IEC 62304, Requirements Specification (2/2) |
14:00 | Software Architecture, SOUP versus OTS |
15:00 | Coffee Break |
15:15 | Software Safety Classification and Interdependency with Risk Management |
15:45 | Software Development Process, Agile Development |
16:30 | Special Topics, Wrap-up, Q&A Session |
17:00 | End |
Agenda of Day 2: Focus Risk Management, Cybersecurity, Special Topics | |
09:00 | Welcome, Expectations (Update) |
09:15 | Risk Management: Introduction, Basics, Definitions |
10:00 | Risk Management: Risk Acceptance |
10:30 | Coffee Break |
10:45 | Risk Analysis |
11:15 | Risk Control |
11:45 | Risk Management Process, ISO 14971, Documentation |
12:15 | Lunch Break |
13:15 | Cybersecurity: Introduction, Basis, Regulations, Model |
13:45 | Cybersecurity: Vulnerability Analysis, Threat Modeling |
14:15 | Cybersecurity as Part of the Development Life Cycle, IT Security Guideline |
14:45 | Coffee Break |
15:00 | Special Topics e.g. Usability & Requirements Engineering, Artificial Intelligence |
16:30 | Wrap-up, Q&A Session |
17:00 | End |
The seminar explicitly addresses:
The seminar is also suitable for persons that are new to regulatory affairs and/or medical device software development.