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.

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.

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)

Medical device regulations tend to be in service of a single goal: to ensure safe medical devices with a positive benefit-risk ratio. It is therefore unsurprising that the notified bodies examine the risk management file most closely in technical documentation submissions and audits.

After this course, you’ll:

• Understand the regulatory requirements for risk management
• Learn the most relevant definitions in the context of risk management
• Learn how to create a risk management file with all the necessary documents including: Risk Acceptance Matrix, Risk Table (with errors, hazards, risks and risk control measures), and Risk-Benefit Assessment
• Learn how to check these documents for legal compliance

We provide templates for a risk management file for certain memberships.