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

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.

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 and examples for TechDok-Pack and Premium-Platinum users to make it even easier to get started.

Medical devices must have a UDI, a unique device identifier, in order to be tracked in the field.

This course will provide you with the basics you need to equip your products with a correct UDI and to meet the regulatory requirements.

Expect the following topics in this course:

• Basics needed to provide products with a correct UDI
• Basics needed to meet the regulatory requirements of MDR and IVDR regarding UDI
• Differences in the requirements for the UDI system from MDR and IVDR
• Know what the Basic UDI-DI is and where it needs to be used
• Knowledge of how the UDI is applied for, allocated and assigned by the issuing entities
• Knowledge about the UDI carriers as well as how to apply these carriers
• Knowledge of the special cases of the UDI for software, implants, systems and procedure packs and configurable devices 
• Knowledge of when a new UDI must be assigned
• Knowledge of the role of the UDI in EUDAMED
• Essential differences between the European and the American (FDA) UDI system
• Knowledge of the transition periods granted by the MDR with regard to the UDI

Your software file demonstrates that you meet the legal requirements for medical device software lifecycle processes. A typical software file includes:

• A software development plan
• Requirements
• Architecture and detailed design specifications
• Results of unit, integration and systems testing
• Release information
• Other maintenance phase and issue resolution documents
  

After this course , you’ll know the relevant regulatory requirements (e.g., IEC 62304) and how to create these individual documents step by step.

Depending on your membership, templates with detailed instructions are available for you to fill out. This speeds up the file creation process even more.

In this chapter, you’ll learn how to create an FDA-compliant usability file that includes all the necessary documents from the use specification to the summative study report. But that’s just the beginning. While the usability validation process is necessary to comply with regulatory requirements, it can also help you develop products that your customers truly love.

Companies that gather precise customer requirements become market leaders—but you can’t get requirements by simply asking for them. Medical Device University has one of the world's best usability engineers in Thomas Geis, who will put you on track to develop usable products by systematically identifying customer requirements and deriving use scenarios and user interfaces from them.

TechDok-Pack and Premium-Platinum members get pre-filled templates with detailed instructions to speed up the file creation process even more. All members can learn from the best with access to 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 provide you with the necessary background knowledge to discuss and argue confidently and at least at eye level with the people auditing you or reviewing your records.

With the suggestions provided by the videos in this course, you will find out with a higher probability and speed whether your products and QM-system actually comply with the requirements of the Medical Device Regulation 2017/745 (MDR). This gives you additional security in case you are audited, for example, during a follow-up audit or in the event that a product later becomes conspicuous on the market.

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)

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.