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.

A lot of medical device manufacturers see the international authorization of their device as a potential hazard: the opportunities offered by new markets are offset by hard-to-calculate risks as well as the time and costs required to obtain these authorizations.

Manufacturers will be better in a better position to manage these risks if they complete these courses. 

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

On April 17, 2020, the German Federal Ministry of Health (Bundesministerium für Gesundheit) presented the preliminary draft of the Digital Health Applications Ordinance, the DiGAV for short. The DiGAV establishes the requirements for the reimbursement of digital health applications (DiGA) by health insurance companies.

Find out what requirements the ordinance establishes for manufacturers so that you can decide whether an application is worthwhile and whether the costs involved are proportional to the expected economic benefits.

The MDR and IVDR contain hundreds of requirements for the manufacturers of medical devices. But these requirements also affect the so-called health care institutions, such as operators of clinics or hospitals.

The understanding of these requirements helps the operators to avoid regulatory problems, and the manufacturers to act more successfully on the market. Because regulatory requirements for the operators also affect the manufacturers.

FDA task series

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 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.

Medical device manufacturers are required to carry out a regular “regulatory update.” Because as strange as it sounds, regulatory requirements oblige manufacturers to continuously monitor and evaluate changes to regulatory requirements and take any necessary measures.

Keeping track of thousands of regulatory requirements is a challenge. Manufacturers should have a clear understanding of the typical mistakes that they should avoid at all costs in order to, firstly, have certainty during audits and, secondly, to save themselves unnecessary time and effort on their “regulatory update.”

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.

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.

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.

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.

For TechDok-Pack and Premium-Platinum members, templates with detailed instructions are available to speed 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.

In the EU, with few exceptions, IFU must be provided in all languages of the member countries where the product is marketed. Numerous standards impose further specific requirements on IFU. Furthermore, the MDR as well as the IVDR require the provision of product-specific training, should this be necessary for the safe use of the product.

Before bringing medical devices to market, manufacturers must minimize their risks and ensure patients' safety. This is monitored by authorities and notified bodies during authorization and conformity assessment procedure.

However, some risks manifest over time, when medical devices are used daily by practitioners.

Post-market surveillance aims at

• systematically identifying these risks when occurring during practical usage
• monitoring the products' performance afield
• detecting product faults and safety issues left undetected
• constantly updating the benefit-risk assessment 
• quickly initiating necessary measures such as recalls

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.

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.

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.

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.

If your product falls under the definition of medical device, you have to comply with laws and standards, and implement quality management systems, software life cycle processes, usability and risk management. You must also provide comprehensive documentation.