IMT Academy
Specialized Webinars for Medtech Professionals
IMT Academy offers specialized online webinars and interactive courses in medical devices, cybersecurity, and product development. Our programs cover the entire product lifecycle, from initial concept and regulatory planning to implementation and market launch. They are tailored to your company’s needs and are ideal for professionals in quality management, regulatory affairs, software development, and product engineering.
Why IMT Academy
Your benefits
Trends & Innovation
Stay updated on the latest medical technology trends.
Practical Knowledge
Learn from expert knowledge and hands-on solutions you can apply immediately.
Industry Expertise
Get professional insights to prepare for real-world industry challenges.
Aftercare
Our experts provide ongoing support for your projects after the webinar.
Expert Networking
Connect with industry professionals, exchange experiences, and expand your network.
Certificate & Materials
Receive a digital certificate and access all course materials.
Workshop topics
All our on-site courses are customized and tailored to the needs and challenges of your team or project. Contact us to find out more. For inspiration, here is a selection (not conclusive) of topics that can be covered, from which we can create a customised course for you on request:
- Spezification with Verification and Validation
- Usability ISO 62366-1
- Design Thinking
- Technical Documentation
- Risk Management ISO 14971
- Patient Safety in Electrical Medical Equipment IEC 60601
- Software Lifecycle Process ISO 62304
- Usability according to IEC 62366-1
- Quality management systems according to ISO 13485
- Quality management systems according to EU MDR
- Quality management systems according to US QSR
- Quality management systems according to ISO 17025 (calibration and test laboratories)
- Conformity assessment according to EU MDR
- Risk management according to ISO 14971
- Conducting internal and supplier audits
- Definition of the standards and laws to be complied with for the quality management system
- Carrying out pre-compliance tests
- Submission of technical documentation to regulatory authorities, notified bodies or certification organizations
- Market surveillance and maintenance
- Creating specifications correctly at various levels
- Creating test protocols for the specifications and their traceability
- Making measurement results traceable to national standards and calculating measurement uncertainties
- Requirements for the technical documentation according to EU-MDR
- Requirements for the technical documentation on post-market surveillance in accordance with the EU MDR
- Check documentation for completeness and close gaps (GAP analysis)
- Obligations of a Class I medical device manufacturer
- Compliance with the essential safety and performance requirements
- Correct registration of medical devices
- Preparation of documentation for monitoring products on the market
- Requirements of the EU MDR and Swiss MepV for Class I medical device manufacturers
- Creation of a design based on the users and their requirements
- Creation of the necessary documentation for the testing and approval of medical devices
- Validation of usability
- IEC 61010: Safety requirements for electrical equipment for measurement, control and laboratory use
- IEC 61326: Electrical equipment for measurement, control and laboratory use - EMC requirements
- IEC 60601: General requirements for basic safety and essential performance
- ISO 80601: Particular requirements for basic safety and essential performance
Individual courses
For individuals looking to attend a course, we currently only offer these in German. If you are interested in booking an individual course, please visit this link to find out more.
Contact
Interested in booking a course for your company or team that's tailored to your needs? We are happy to help you.
Katharina Maul
Head of IMT Academy
Regulatory Affairs- &
Quality Manager