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What happens if questions or problems arise?  
What happens if questions or problems arise? If you experience technical problems while participating or have any other questions, you can contact our support team anytime, even at short notice. The…  
Get to know your trainer  
Margret Seidenfaden studied medical technology and business administration and has several years of experience in interna­tional medical device approval. After working for medical device…  
Johner Academy  
Education and training reinvented: With the Johner Academy, you will become a qualified contact person for regulatory questions.  
Authorized Representative Services & Regulatory Roles  
We support you in successfully expanding into new markets – as a legal manufacturer, PRRC, authorized representative, or in other regulatory roles.  
Outsourcing  
We handle your regulatory and administrative tasks efficiently, compliantly, and cost-effectively – e.g., as legal manufacturer in the EU or US agent.  
Assisted Self-Service  
With our self-service solutions, we aim to support startups and manufacturers with limited budgets in overcoming regulatory hurdles on their own.  
Information Security Management System  
With a lean Information Security Management System (ISMS), we help you to effectively protect your data and fulfill the requirements of ISO 27001.  
Management Systems  
We support medical device manufacturers, their service providers, and laboratories in setting up, continuously improving, and integrating management systems.  
Integrated Management Systems  
We help you efficiently integrate your management systems, such as those in accordance with ISO 13485, ISO 9001, or ISO 27001, thereby saving costs.  
AI Act – Self Study  
Thanks for letting us know! It's great that you want to expand your knowledge to fulfill the requirements of the EU AI Act yourself.  We will send you further content soon to support you…  
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