Software as Medical Device
Overview & Roadmap for CE Certification
For digital health start-ups, the CE marking process is in many cases a major challenge. The MDR regulation imposes strict requirements for placing medical devices on the market and monitoring them. This course provides a low-threshold, practical overview of the CE certification process to help you bring your software to the market as a medical device as quickly and safely as possible.
Course Content
10 Course ModulesSelf-paced digital modules with a final Q&A session led by industry experts.
CE Certification Roadmap:
Overview of relevant standards, laws, and regulations to guide you through the legally compliant CE marking process within the EU.
Intended Use & Risk Classification
When is software considered a medical device? Focus on Rule 11 of the MDR and MDCG 2019-11.
General Safety and Performance Requirements
In-depth look at Annex I of the MDR and key requirements for product safety and efficacy.
Quality Management According to ISO 13485
Standards for managing quality processes in medical device manufacturing.
Risk Management According to ISO 14971
Structured approach to identifying, assessing, and controlling product risks.
Clinical Evaluation
Systematic analysis of clinical data to confirm product safety and performance.
Technical Documentation
Comprehensive documentation of design, function, and regulatory compliance, especially for digital products.
Conformity Assessment & Market Launch
Covers instructions for use, PRRC, UDI, databases like EUDAMED, and CE marking.
Post-Market Surveillance (PMS)
Ongoing monitoring after market launch to ensure continued product safety.
Special Requirements for Risk Class II and Above
Includes audits, PMS reporting, safety update reports, cybersecurity, and more.
Q&A Session
Interactive session with industry experts to discuss course topics and your questions.
Methods
- Web lectures
- Practical tutorials
- Supporting literature and course script
- Real-life examples and templates
- Live Q&A with industry experts
Target Audience
This course is designed for everyone involved in the development and commercialization of digital health solutions, including:
- Founders
- Software developers and architects
- Project managers
- Regulatory affairs and quality management professionals
Instructor
Angela SpechtRegulatory Affairs Specialist, KREWI Medical Produkte GmbH
Ilja MichaelisGeschäftsführer Routine Health GmbH
Investment
€299 excl. VAT