The Medical Device University empowers MedTech professionals to master the complexities of regulatory affairs. Our eLearning platform offers you the knowledge and tools to bring your medical innovations to market with confidence.
Whether you’re navigating early-stage development or preparing for global market approval, our expert-led courses are designed to guide you every step of the way.
Join us to ensure your medical devices meet the highest standards of safety and compliance, and take your MedTech journey to the next level.
Video: Discover Medical Device University!
Watch our video for a full overview of Medical Device University’s features. See how our eLearning platform provides expert-led courses, real-world case studies, interactive tools, and up-to-date regulatory guidance. Learn how we help you master compliance, accelerate market approval, and bring your medical devices to the world—efficiently and safely.
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Why Choose Medical Device University?
In the rapidly evolving MedTech industry, staying ahead of regulatory requirements is crucial. The Medical Device University offers a unique blend of expert knowledge, practical tools, and flexible learning designed specifically for professionals like you. Here’s why we’re the go-to resource for MedTech innovators:
Expert-Led Courses
Learn from industry leaders with decades of experience in medical device regulations.
Comprehensive Curriculum
Our courses cover every aspect of regulatory affairs, from basic principles to advanced strategies.
Flexible Learning
Access our platform anytime, anywhere, and learn at your own pace to fit your busy schedule.
Practical Tools and Resources
Benefit from templates, checklists, and real-world examples that you can immediately apply to your work.
Who We Help
Medical Device University is designed to support a wide range of professionals in the MedTech industry. Whether you’re just starting out or you’re an experienced professional, our platform can provide the knowledge and resources you need to succeed. Here’s a look at who can benefit from our eLearning courses:
Startup Founders
Navigate the complex regulatory landscape with confidence and bring your innovative medical devices to market.
Regulatory Affairs Professionals
Stay ahead of the latest regulatory requirements and ensure your organization’s compliance.
Quality Assurance Managers
Learn best practices for developing and maintaining robust quality management systems.
Product Development Teams
Gain insights into the regulatory considerations that must be addressed throughout the product lifecycle.
Course Overview
Determining whether your product is a medical device or IVD is crucial, as it will significantly affect its development, marketing, servicing, and regulatory requirements, and this guidance will help you understand the qualification process, define the intended use and purpose of your device, explore its classification and its impact on approval efforts, and learn about the general safety and performance requirements.
If your product is classified as a medical device, you must meet specific regulatory requirements, and in this course, you will gain an overview of the legal system for medical devices and learn about key topics such as:
- Medical device regulations
- Essential requirements you or your product must meet
- Conformity assessment procedures
- Harmonized standards
- Key differences between the European and US legal systems
In vitro diagnostic (IVD) devices are medical devices, usually kits, assays, or laboratory devices, used to analyze body samples for medical purposes, and if your product is an IVD, you must comply with the regulatory requirements under IVDR, with this course providing an overview of the legal system and covering:
- How to qualify, e.g. find out if your product is an in vitro diagnostic medical device
- How to classify IVDs
- How to create a plan to implement the regulatory requirements
- And finally how to verify compliance with the regualtion.
Your path to FDA approval: Welcome to our FDA approval course. You will have your first FDA filing file in your hands by the end of this course. Start right away with the first video. Our FDA expert Luca Salvatore will guide you through this course.
This course is currently under construction. If you have any questions, please feel free to email us at: elearning@johner-institut.de.
By completing this course, you’ll learn how to write precise, streamlined intended purposes that meet regulatory requirements, ensuring successful qualification, classification, and approval of your products, and you’ll have an approved intended purpose for one product that can serve as a model for future use in your company.
The technical documentation (TD) for every medical device must be created in accordance with the MDR and IVDR to allow for the assessment of conformity, and this course is designed for those who compile, check, submit, receive, or review the TD, helping you create a structure for it and ensure its completeness, consistency, and conformity.
This course will help you establish an ISO 13485 and FDA-compliant Quality Management (QM) system, create a QM manual with necessary policies and objectives, identify processes and formulate standard operating procedures (SOPs), and prepare your QM system for internal and external audits, with guidance from Medical Device University and the Johner Institute team to ensure you have a manageable Quality System that accelerates your product timeline while staying audit-ready.
Regardless of the type or class of medical device you’re marketing, or whether you need a notified body, you must establish a Person Responsible for Regulatory Compliance (PRRC) as required by EU regulations, and this course covers the PRRC’s role as per MDR/IVDR Article 15, the requirements for having a PRRC, their responsibilities in product assessment, technical documentation, post-market surveillance, vigilance, reporting, and testing, and how to find and integrate a suitable PRRC in your company, including registration in EUDAMED.
Medical device regulations aim to ensure safe devices with a positive benefit-risk ratio, which is why notified bodies closely examine the risk management file during technical documentation submissions and audits, and after this course, you’ll understand the regulatory requirements for risk management, learn relevant definitions, create a risk management file with necessary documents like the Risk Acceptance Matrix and Risk Table, check these documents for legal compliance, and receive templates and examples for TechDok-Pack and Premium-Platinum users to simplify the process.
Medical devices must have a unique device identifier (UDI) to be tracked in the field, and this course will equip you with the basics to provide your products with a correct UDI, meet the regulatory requirements of MDR and IVDR, understand differences in UDI system requirements between the two, know about the Basic UDI-DI and its usage, learn how UDIs are applied, allocated, and assigned, understand UDI carriers, special cases for software, implants, and other devices, know when a new UDI is required, learn the role of UDI in EUDAMED, compare European and American UDI systems, and understand transition periods granted by the MDR.
Your software file demonstrates compliance with legal requirements for medical device software lifecycle processes, and this course will teach you the relevant regulatory requirements (e.g., IEC 62304) and guide you step by step in creating individual documents such as a software development plan, requirements, architecture and design specifications, testing results, release information, and maintenance phase documents, with templates and detailed instructions available depending on your membership to speed up the process.
In this chapter, you’ll learn how to create an FDA-compliant usability file with all necessary documents, from the use specification to the summative study report, and discover how the usability validation process not only ensures regulatory compliance but also helps you develop products that customers love, with guidance from usability expert Thomas Geis on systematically identifying customer requirements and deriving use scenarios and user interfaces, while TechDok-Pack and Premium-Platinum members get pre-filled templates with instructions to speed up the process, and all members can access our video training series.
The goal of clinical evaluation is to demonstrate that your product:
- Provides the expected benefits,
- has the promised performance characteristics,
- and has no unknown side effects or risks.
Clinical evaluation is required by law.
In this course, you will learn:
- The regulatory requirements for clinical evaluation.
- The content that a clinical evaluation must contain.
- How to proceed to get this content and
- how to document the results.
With clinical evaluation, you don’t just want to meet regulatory requirements. You really want to be sure you are benefiting your patients and not exposing them to unnecessary risk.
This course will equip you with the knowledge to confidently engage with auditors and reviewers, helping you assess more quickly and accurately whether your products and QM system comply with the Medical Device Regulation 2017/745 (MDR), providing added security in case of follow-up audits or market issues with your product.
Authorities and notified bodies are increasingly making Computer System Validation (CSV) the subject of audits.
This course will introduce you to the world of CSV and equip you to perform validation on your own, and shine in audits. In addition to the actual process of validation, you will also learn about the regulations that require CSV.
Reading course:
Regulations such as the MDR require proof of biocompatibility for all materials that come into direct or indirect contact with patients or users.
Learn in this reading course:
- which standards are applicable for your products (EN ISO 18562 vs ISO 10993)
- what needs to be done to prove biocompatibility
- what you need to consider when your products need to be reprocessed and
- what to consider when choosing the right laboratory for cytotoxicity testing
IT security is a prerequisite for medical devices to be used safely and deliver their promised benefits.
This course covers regulatory requirements, as well as methods to identify, avoid and eliminate security vulnerabilities.
The following topics are part of this course:
- the protection goals in IT security
- regulatory requirements for IT security of medical devices in the EU and the USA
- methods to identify vulnerabilities in systems, in products or components
- basic knowledge of penetration testing (procedure and methods)
In this series, you will learn about the use of artificial intelligence in medicine and medical devices, gain insights into the development effort involved, familiarize yourself with various methods, understand how these systems work, and recognize the regulatory requirements, with a focus on AI procedures, their capabilities, and limits, while also understanding how to check for product compliance and quality. Note that the AI-Act is not covered in this course, as a separate course is being developed for it.
Get in Touch
Ready to take the next step in mastering MedTech regulations? Contact us today to learn more about how Medical Device University can support your journey. Whether you have questions, need guidance, or want to discuss your specific needs, we’re here to help.