Is your product a medical device? The answer to this crucial question will have a major impact on the way you can develop, market and service your product.

With this short introduction into regulatory requirements, we would like to provide some guidance for deciding whether your product is a medical device or IVD or not. This is called qualification.

In this context, it is important that you precisely define the intended use and intended purpose of your device.

We also would like to give some insights on classification. This classification has a distinct impact on the efforts you make to approve your device.

Finally, you will learn some of the general safety and performance requirements.

If your product is classified as a medical device, you must meet certain regulatory requirements. In this course you will get an overview of the legal system as it pertains to medical devices and learn about important 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, typically kits, assays, or laboratory devices used to analyze samples derived from the body for a medical purpose.

If your product is an in vitro diagnostic medical device, you must comply with the regulatory requirements by IVDR. In this course, you will get an overview of the legal system and learn:

• 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.

Welcome to the practical course on FDA approval.

You will learn how to create a complete submission file and prepare a 510(k) submission in eSTAR format. Our FDA AI-expert will guide you step by step through regulations, submission formats and approval procedures. Upon completion, you will be able to recognise FDA letters, understand substantial equivalence and use the Q-Submission program. We will also show you the requirements for QM systems in accordance with the new QMSR and those for reporting (eMDR, corrections and removals).

Start now with the first video and create your submission file.

Overview of the core content of the course:

• Regulations and classification in the USA
• Submission formats and eSTAR examples
• Approval procedures and 510(k) procedure
• FDA letters, substantial equivalence, Q- Submission
• QMSR requirements and eMDR reports
• Practical example: 510(k) file in eSTAR format

Large Language Models (LLMs) such as ChatGPT are fundamentally changing the development, approval, and quality assurance of medical devices. In this course, you will learn how to use this technology effectively and safely in a regulated environment, from conception and implementation to institutional integration.

In a series of practical tasks (sprints), you will learn:

• Basics and Definitions: Where LLMs can be used effectively in the medical device ecosystem and what limitations are important.
• Context Engineering and Prompting: How to obtain reliable answers using structured queries and retrieval techniques.
• Validating Model Outputs: Quality assurance and regulatory compliance of AI-generated content.
• Advanced Techniques: From the use of structured data to the complete context engineering process.
• Institutionalization: Building your own Custom GPTs, workflow integration, and use in teams.
• Regulatory Aspects: AI Act, ISO 13485, and requirements for computerized systems.
• AI-first strategies: How companies make AI a key success factor.

By the end, you will be able to use LLMs not only efficiently but also compliantly in development, quality assurance, and documentation.

Your mission, if you choose to accept it, is to become a recognized expert in intended purposes. After this course, you'll write intended purposes that are as precise as they are streamlined, and that you can be assured will stand up in reviews and approvals.

You will be well aware how critical these intended purposes are to the qualification, classification and approval of your products. But you will also know all the regulatory requirements and how to write these documents quickly and effortlessly.

However, your mission goes further: At the end of this course, you will have a perfect and approved intended purpose for one of your products. An intended purpose that provides a solid foundation for your product's development and post-market surveillance. An intended purpose that will be used as a model in your company in the future.

The technical documentation (TD) must be created for every medical device. According to the MDR and IVDR, the technical documentation must be such that the assessment of the conformity of the medical device with the IVDR/MDR is possible through the TD.

We have created this course for all persons:

• who compile a technical documentation,
• who check the compilation and submit the documents,
• who receive and review them, or short for all those
• who are responsible for this.

This course aims to support you in precisely these tasks. You will then be able to create a structure for your technical documentation and check the TDs, not only for completeness, but also for consistency and conformity.

This course will help you accomplish the following goals:

• establish an ISO 13485 and FDA-compliant Quality Management (QM) system
• create a QM manual with the necessary policies and objectives * Identify processes and formulate standard operating procedures (SOPs)
• repare your QM system for internal and external audits

If that sounds like a lot, it is! But Medical Device University and the Johner Institute team will guide you every step of the way. In the end, you’ll have a Quality System that is manageable for you, to help you rise above QM bureaucracy and accelerate your product timeline—all while staying prepared for any audit or inspection.

So, what are you waiting for? Let’s get started.

Regardless of the types of medical device you are marketing, regardless of their class and regardless of whether you need a notified body for this or not: you need to establish a person responsible. Unfortunately, EU regulations do not grant you a transition period for this. 

Since you need to register this responsible person, authorities can easily check whether you are meeting the regulatory requirements.

This course covers:

• Role of the Person Responsible for Regulatory Compliance (PRRC) as per MDR/IVDR Article 15 and relevant regulation
• Who needs a PRRC and the difference between having one and having access
• Qualification requirements for a PRRC
• PRRC's responsibilities defined by MDR/IVDR
• PRRC's involvement in product assessment, Technical Documentation, and Post-Market Surveillance
• PRRC's role in vigilance, reporting, and testing
• Finding suitable PRRC candidates and integrating the role in your company (insurance, organization, contract, division of responsibility, EUDAMED registration)