TITLE

Quick access to EU market for innovative medical solutions – overcoming regulatory hurdles/challenges

EXPERT

Mario is the founder and general manager of suxeo. He has a graduation in biomedical engineering from the Dresden University. Before founding suxeo, Mario spend 13 years working as an embedded engineer at Schiller AG Switzerland and developed cardiology devices such as ECG, patient monitoring systems and rescue defibrillators. One of his skills is combining the knowledge from physiological nature of the human body with state of the art therapeutic and diagnostic technologies to build innovative applications. Today Mario helps companies to understand and execute standards (e.g. IEC 60601-1, IEC 62304, IEC 62366, ISO 14971) and medical systems engineering with focus on safety, security and performance. He also serves as trainer and coach for start-up companies developing active medical devices and active implants. Since 2015 Mario serves as chairman of the association Certified Professional for Medical Software.

Mario Klessascheck, Dipl. Ing. ET

Medical device expert

LEARNING OBJECTIVES

After the workshop the participant is able to:

  • eflect the European medical device framework and CE marking
  • analyze, if a software needs to be classified as a medical device
  • distinguish between: medical apps, medical device software and software medical device
  • determine a medical devise classification according to the new rules of MDR (specially for stand-alone software)
  • reflect the most important standards a product has to comply with for CE marking (ISO 14971, IEC 62304, IEC 62366, IEC 60601-1)
  • understand the importance of risk management and how to set up software development plan in relation to software safety classification
  • using and distinguish the terms: hazard, harm, hazardous situations, risk/benefit and their relations
  • differentiate between safety and security (e.g. Cybersecurity)

AGENDA - 15 May 2019, 9-13.30

The agenda assumes an approximately four-hour workshop:

  1. Short introduction to the new MDR and the regulation framework in Europe (the challenge for medical apps and telemedicine applications)
  2. Strategy for classification of medical device components in distributed systems
  3. Introduction to risk management framework according to ISO 14971
  4. Introduction to software-life-cycle process according to IEC 62304
  5. Planning usability activities according to IEC 62366
  6. Brief introduction to IT-Security and Cybersecurity – regulations and standards
  7. Documentation - compiling the Medical Device File for submission
  8. Answering questions (also during the workshop)
ORGANIZERS
PARTNERS

For registration, please contact: krzysztof.malinowski@umed.wroc.pl

Number of places limited