Seminar "Certified Professional for Medical Software"
This training is the ideal preparation for the examination „Certified Professional for Medical Software“.
The training covers the following subject matters:
Regulatory Basics, e.g. directives, laws and regulations, conformity assessments
Quality management according to ISO 13485
Risk management according to ISO 14971
Software development life cycle according to IEC 62304
Usability Engineering according to IEC 62366
Technical documentation for software
Selected topics of medical informatics
Goals
The training will provide lasting benefits to you:
You will have the best chances to pass the exam "Certified Professional for Medical Software". Read below why!
You will train with realistic, memorable case studies. So you will be able to transfer the subjects to your projects and your company easily.
You coaches are auditors, train notified bodies and support medical device manufacturers to pass audits. You will get advice about how to pass the next audit successfully.
Prior participants did not only honour the acquired competences, but also the lively presentation in the training.
Included in the training:
The arrangement of the exam. The exam itself will be conducted by an independent, accredited exam organisation. The exam fee of 200€ / person will be charged in addition to the training fee.
| Date | Topic |
| Day 1 | |
| Morning | Welcome, Expectations, Introduction, Regulatory Landscape, Differences EU / FDA |
| Afternoon | Document Management, Quality Management & ISO 13485 |
| Day 2 | |
| Morning | Quality Management II, Risk Management & ISO 14971 |
| Afternoon | Risk Management II, Usability & Requirements Engineering & IEC 62366 |
| Day 3 | |
| Morning | Usability & Requirements Engineering II, Medical Informatics |
| Afternoon | Software Engineering & IEC 62304 |
| Day 4 | |
| Morning | Software Engineering II |
| Afternoon | Questions and Answers, Exam Preparation, Examination |
Target Group
The training "Certified Professional for Medical Software" is intended for everyone interested in standard compliant development of medical devices including software, or standalone software as a medical device.
Especially:
System and Software Engineers
System and Software Architects
Project Managers
Regulatory Affairs Managers
Quality Managers, and
Product Managers
Notified Bodies also participate in our trainings regularly.
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