Past Events

SHS Webinar: Sculpting the Future of eHealth: SaMD Development Essentials

April 17, 2024

Online, 12:00-13:00

Embark on the path to SaMD excellence with Swiss Healthcare Startups and Congenius AG...

Are you ready to ensure your health software not only complies with regulatory frameworks but also excels in market performance?

Navigating the terrain of Software as a Medical Device (SaMD) can be as complex as it is critical. To help you on the journey, the team of eHealth experts at Congenius AG has crafted a must-attend webinar exclusively for the visionaries at Swiss Healthcare Startups.

Join us at noon on 17 April for "Sculpting the Future of eHealth: SaMD Development Essentials," to gain insights into:

  • Is my health software SaMD? Identifying whether your software meets the SaMD criteria
  • Classifying your SaMD: Understanding the classification tiers to align your development strategy
  • Defining the Regulatory Pathway: Charting the course for regulatory navigation and market entry
  • Using standards to prove compliance: Leveraging international standards to demonstrate your commitment to quality and safety
  • Operating Controlled Design: Mastering the design controls that keep your development process on track
  • Managing Risk: Cultivating a proactive approach to risk management throughout your SaMD's lifecycle
  • Usability and Human Factors Engineering: Designing with the user in mind to enhance the experience and outcome
  • Building up the Technical Documentation: Crafting comprehensive documentation that supports your SaMD's journey
  • Clinical Evaluation of SaMD: Proving the benefit of your SaMD based on your clinical claims
  • Post-Market Surveillance of SaMD: Ensuring continuous improvement and vigilance after market launch


Reserve your place today to join the ranks of SaMD producers who are redefining healthcare innovation.