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

Here you can find additional information regarding the next training dates, prices and registration. If the overview table does not say otherwise, there are still seats available.

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.

Content

Date Topics
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.