Learn how to coordinate the necessary risk management activities and create compliant documentation for your medical devices.
This seminar will provide you with the necessary competencies to perform effective audits as an internal auditor in your company.
Learn what ISO 13485:2021 requires and how your company can confidently pass audits while reducing QM bureaucracy.
This seminar helps you understand the principles and requirements of the MDSAP and derive the necessary preparatory measures.
The five-day course helps you understand the requirements of ISO 13485 and apply them successfully as a lead auditor.
Learn to understand the requirements of MDR/IVDR and ISO 13485 for purchasing and supplier management in detail and apply them accordingly in your company.
In this seminar, you will learn about the ISO 15189:2022 requirements for quality and competence in your health institution and how to implement them.
Learn how to seamlessly integrate ISO 42001 into your ISO 13485 and ISO 27001 management systems in two half-days – with a ready-made project plan.
Learn how to successfully implement the requirements of the IEC 60601 family of standards in practice and ensure standard-compliant documentation.
In this seminar, you will get the necessary knowledge and tools to test the biological safety of your medical device and document it compliantly.
This seminar helps you develop medical device software that uses AI methods in compliance with the law and bring it to market as quickly as possible.
This practice-oriented workshop will teach you how to use AI assistants for regulatory tasks and document analysis effectively.
How to remain cost-efficient and flexible with precise and efficient production while complying with the strictest quality standards and requirements.
In this practical e-learning course, we provide step-by-step support to help you understand and implement the requirements of the EU AI Act.
Learn how to implement the AI Act for your medical and IVD medical devices in a legally compliant and efficient manner, thereby avoiding compliance risks.
AI in medtech development: Learn how to rapidly accelerate development times and remain MDR compliant with hands-on exercises.
Here, you can find out what AI coding tools can do in practice, what pitfalls they entail, and how you can handle them appropriately.
This practical seminar helps you, as an author, plan your clinical evaluation optimally, carry it out efficiently, and document it compliantly.
We introduce you to the clinical evaluation process and show you how to review and assess clinical evaluation files in a targeted manner.
Learn how to conduct targeted and successful literature research as part of your clinical evaluation and document it in accordance with MDR.
In this practice-oriented workshop, you will learn how to increase the efficiency of your clinical evaluations through the targeted use of AI tools.
Learn about the regulatory requirements for IT security and data protection for medical devices and how to implement them professionally in your company.
Learn how to validate your computerized systems in a risk-based, fast, and regulatory-compliant manner and document it accordingly.
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In this seminar, we show you how to optimally design your development process and document it in accordance with regulatory requirements.
This seminar will optimally prepare you to meet the regulatory requirements for your medical software.
Gain the necessary competencies for the development of secure software devices – specific to your programming language and platform.
You get a compact overview of the most important requirements of the MDR and learn how to implement them efficiently and within the applicable transition periods.
Learn about the regulatory requirements for post-market surveillance (PMS) and how to implement them in your company without unnecessary effort.
We help you navigate the regulatory jungle and label and register your medical devices in accordance with the MDR.
You will gain an overview of the most important regulatory requirements, relevant standards, guidelines, and best practices in Europe.
Learn about the components of technical documentation in accordance with the IVDR requirements and how to implement them with minimal effort and cost.
Gain a detailed understanding of the IVDR requirements for in-house IVD and learn what needs to be done and in what order.
Learn how to plan the individual performance evaluation of your IVD medical device in a targeted manner and implement the requirements of the IVDR in a device-specific way.
Learn how to carry out the systematic literature search required by the IVDR in a structured and efficient manner and document it comprehensibly.
Learn about the components of technical documentation for in-house IVD medical devices and how to implement them with minimal effort and cost.
We will enable you to fulfill your (new) role as a medical device consultant in accordance with the MPDG and competently implement the legal requirements.
In this seminar, you will learn about the tasks and duties of the PRRC and how to perform the role in the company in accordance with the requirements.
We guide you through the usability evaluation process for your medical devices – in accordance with regulatory requirements and without unnecessary effort.
Learn how to efficiently perform formative and summative usability evaluations and conduct your own usability test in the lab.
Learn about the basic requirements that the FDA imposes on the marketing of medical devices, which you and your company must know, understand, and fulfill.
This seminar helps you optimally prepare yourself for an FDA inspection. That way, nothing will stand in the way of a successful inspection.
This seminar will help you understand the FDA's new requirements for your quality management system and implement them in your company successfully.
In this seminar, you will learn about the FDA's 510(k) procedure and, using concrete examples and exercises, how to implement the requirements.
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