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.