Success Story: Building competence in healthcare software regulatory compliance

Train the Trainer course on Monday 14 October 2024 (13:00-14:00 CEST) and will cover the following key topics:

1. Building Core Competence in SMEs for Premarket Submissions in Digital Health Participants will be introduced to the most common types of premarket submissions for digital healthcare technologies. They will learn how to determine if their technology qualifies as a medical device, assess the associated risks, understand the requirements for developing technical documentation, and effectively prepare a premarket submission. 
2. Success Story: Medicue
   A case study on Medicue, an SME specializing in digital healthcare solutions, highlighting their customer needs, solutions, results, and the impact of their approach.
3. Regulatory Compliance for Healthcare Software
   The course will provide guidance on mapping premarket submission processes, understanding regulatory requirements, and managing submissions to ensure smooth market entry for healthcare solutions.
4. Lessons Learned and Key Takeaways
   The session will share practical insights and recommendations, focusing on improving communication, including more practical use cases, and fostering collaboration within the regulatory framework.

Course agenda:

• Overview: IT & Cloud Computing in Healthcare

• SME Success story: Medicue 

  • Customer needs

  • Customer solution

  • Results and impact

  • Lessons learned

  • Key takeaways

• Questions & answers (participant discussion)

To enrol in and access this course and materials, please visit the eLearning Platform. 

Course provider: EDIH Nemonoor