Seminar “Medical Device Regulatory Affairs” (in English)
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Learning objectives
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:
- Regulatory framework: The participants are aware of the relevant regulations, directives, guidelines, laws and standards and the interdependencies. The understand the major changes the EU regulations (MDR, IVDR) introduce in comparison to the EU directives.
- Medical device approval: The participants know the different approval processes in the EU and the US, the respective preconditions such as quality management systems and the dependency of these processes on medical device classification.
- Medical device software and IEC 62304: The participants understand the requirements laid out by IEC 62304, know how to compile a software requirements specification and a software architecture. They can explain core concepts such as software safety classification and SOUP and have an understanding how to
- Risk Management and ISO 14971: The participants can precisely use the terms harm, hazard, hazardous situation, risk and severity. They know how the risk acceptance matrix and clinical evaluation have to interact. They have an understanding of the most relevant techniques for risk analysis (PHA, FMEA, FTA) and know options for risk control.
- Cybersecurity: The participants understand how risk analysis and cybersecurity / vulnerability analysis work together and know how the cybersecurity related activities can be woven into the software development process.
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 |
Target Group
The seminar explicitly addresses:
- Project and product managers for active medical devices
- System and software developers, system and software architects
- Regulatory affairs manager
- Quality manager
The seminar is also suitable for persons that are new to regulatory affairs and/or medical device software development.
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