IMT Academy
Enhance your team's expertise with custom on-site trainings
IMT Academy offers specialized, on-site courses designed to meet the specific needs of your company. Our courses are ideal for professionals involved in quality management, regulatory affairs, product development, and more.
Target Audience
Our courses are ideal for professionals working in quality management, regulatory affairs and development. Suitable for companies that manufacture medical devices or electronic devices and work in regulated environments.
- Regulatory Affairs
- Quality Management
- Research & Development
- Project Managers
- Product Managers
- Engineers
- Importers / Distributors
- Other interested parties
Advantages for course participants
Benefit from leading experts in the medical technology industry. Our speakers share their in-depth specialist knowledge and tried-and-tested methods. This will give you unique insights and prepare you for challenges.
Our courses offer you directly applicable knowledge. With case studies and templates, you will acquire skills that you can use immediately in your professional field and develop efficient solutions to complex problems.
Take the opportunity to network with medical technology professionals. Exchange experiences and expand your professional network to gain new perspectives.
Keep up to date with the latest trends and technologies in medical technology. Our courses integrate current developments to keep you at the forefront of innovation and give you a competitive edge.
We continue to offer you access to our experts for additional support and advice. Benefit from our extensive know-how in the long-term and implement expertise in your projects with confidence. For more information about the possibilities of ongoing collaboration, don't hesitate to get in touch with us without obligation.
Your team members who have completed training will receive a training certificate for each course.
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.
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:
- 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
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