REF. GR03 – INTRA / INTER
MANAGING RISKS
COURSE DESCRIPTION
At the end of this course, participants will understand the concepts set out in EN 62304:2006/AC 2008/A1:2015 regarding software development and better grasp the regulatory and normative requirements governing market authorization for medical devices (MD) with incorporated software or stand-alone software as a medical device in Europe. They will also be able to identify the documentary deliverables required based on the Software Safety Classification.
DURATION
1 day / 7 hours
IN-PERSON
VIRTUAL CLASSROOM
OBJECTIVES
- Identify regulatory requirements for MD software
- Understand the specificities of the different types of software, which implies a thorough understanding of their development
- Distinguish and understand the ties between the Analysis and Management of MD Risks and the Software Safety Classification
- Identify the normative requirements for the development of MD software
TARGET TRAINEES
MD manufacturers, and more particularly:
- R&D Manager
- Software Development Manager and any individual who works on the development of software and/or MD design/development
- The individual responsible for ensuring compliance with the regulations
- Quality Manager
- Regulatory Affairs Manager
PREREQUISITES
- Familiarity with the MD sector
- Familiarity with software concepts
TRAINING RESOURCES
- PowerPoint presentation handed out at the end of training
- Case studies
- Reference to Regulation (EU) 2017/745
- Quizzes
COURSE CONTENT
Participants welcomed and presented/Presentation of the course objectives and method to check that they are achieved:
- Identify regulatory requirements for MD software
- Understand the specificities of the different types of software, which implies a thorough understanding of their development
- Stand-Alone Software
- Software embedded in a microprocessor or microcontroller
- Software embedded in another component (firmware)
- Distinguish and understand the ties between the Analysis and Management of MD Risks and the Software Safety Classification according to EN 62304
- MD software development process
- Summary/Q&A
- Training evaluation and conclusion
Virtual classroom training: the course can be divided into two half-days.
EVALUATION METHODS
- Course evaluation quiz
- Satisfaction survey
- Attendance certificate
This training is assessed based on an evaluation of each individual’s acquisition of knowledge via quizzes during and at the end of the program (success criteria >= 75%).
