Medical Device Regulatory Affairs (in English)

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.