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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.
Name | Watched | Assessments | ||
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Introduction - Qualification | Not available in current plan. . | Book a free demo | ||
Intended Use and Intended Purpose | Not available in current plan. . | Book a free demo | ||
Classification | Not available in current plan. . | Book a free demo | ||
General Safety and Performance Requirements | Not available in current plan. . | Book a free demo |
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:
Name | Watched | Assessments | ||
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Welcome | Not available in current plan. . | Book a free demo | ||
Introduction | Not available in current plan. . | Book a free demo | ||
Essential requirements | Not available in current plan. . | Book a free demo | ||
Classification | Not available in current plan. . | Book a free demo | ||
Conformity assessment | Not available in current plan. . | Book a free demo | ||
Unique Device Identification | Not available in current plan. . | Book a free demo | ||
Clinical Evaluation & PMCF | Not available in current plan. . | Book a free demo | ||
Post Market Surveillance | Not available in current plan. . | Book a free demo | ||
Roles | Not available in current plan. . | Book a free demo | ||
Quality Management | Not available in current plan. . | Book a free demo |
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:
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.
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Introduction to QMS and ISO 13485 | |||
About this series | Not available in current plan. . | Book a free demo | ||
Basic principles | Not available in current plan. . | Book a free demo | ||
The route to the QM-System | Not available in current plan. . | Book a free demo | ||
Standards and regulations | Not available in current plan. . | Book a free demo | ||
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QM Manual | |||
QMM 1: Quality Policy | Not available in current plan. . | Book a free demo | ||
QMM 2: Quality objectives | Not available in current plan. . | Book a free demo | ||
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QM system: roles and responsibilities | |||
Roles and responsibilities 01: Fundamentals | Not available in current plan. . | Book a free demo | ||
Roles and responsibilities 02: Regulations | Not available in current plan. . | Book a free demo | ||
Roles and Responsibilities 3: QM Representative | Not available in current plan. . | Book a free demo | ||
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QM-System: Processes and procedures | |||
Processes and procedures | Not available in current plan. . | Book a free demo | ||
Compiling lists of SOPs | Not available in current plan. . | Book a free demo | ||
Writing SOPs | Not available in current plan. . | Book a free demo | ||
Writing SOPs II | Not available in current plan. . | Book a free demo | ||
How to write SOPs? | Not available in current plan. . | Book a free demo | ||
SOP review, communicate, train | Not available in current plan. . | Book a free demo | ||
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QM-System: Document Control | |||
Basics | Not available in current plan. . | Book a free demo | ||
Regulations | Not available in current plan. . | Book a free demo | ||
Determining measures | Not available in current plan. . | Book a free demo | ||
Writing SOPs | Not available in current plan. . | Book a free demo | ||
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QM-System: Development | |||
Introduction | Not available in current plan. . | Book a free demo | ||
ISO 13485 | Not available in current plan. . | Book a free demo | ||
ISO 9001:2015 | Not available in current plan. . | Book a free demo | ||
IEC 62366-1:2015 | Not available in current plan. . | Book a free demo | ||
IEC 60601-1 | Not available in current plan. . | Book a free demo | ||
IEC 62304 | Not available in current plan. . | Book a free demo | ||
Writing options | Not available in current plan. . | Book a free demo | ||
Structure | Not available in current plan. . | Book a free demo | ||
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QM-System: Risk Management | |||
SOP on Risk Management | Not available in current plan. . | Book a free demo | ||
Synchronize development process | Not available in current plan. . | Book a free demo | ||
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QM system: Management Review | |||
Management review regulations | Not available in current plan. . | Book a free demo | ||
Writing management review SOPs | Not available in current plan. . | Book a free demo | ||
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QM system: Internal Audits | |||
Introduction | Not available in current plan. . | Book a free demo | ||
Regulations | Not available in current plan. . | Book a free demo | ||
Writing SOPs | Not available in current plan. . | Book a free demo | ||
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QM system: Purchasing | |||
Introduction | Not available in current plan. . | Book a free demo | ||
Regulations | Not available in current plan. . | Book a free demo | ||
Writing SOPs | Not available in current plan. . | Book a free demo | ||
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QM system: Feedback-Measures | |||
Introduction | Not available in current plan. . | Book a free demo | ||
Regulations | Not available in current plan. . | Book a free demo | ||
Vigilance | Not available in current plan. . | Book a free demo | ||
CAPA | Not available in current plan. . | Book a free demo | ||
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QM system: Training | |||
Training 1: Introduction | Not available in current plan. . | Book a free demo | ||
Training 2: Regulations | Not available in current plan. . | Book a free demo | ||
Training 3: SOP on training | Not available in current plan. . | Book a free demo | ||
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QM-System: Sales | |||
Sales 1: Intro | Not available in current plan. . | Book a free demo | ||
Sales 2: Risks | Not available in current plan. . | Book a free demo | ||
Sales 3: Actions and SOPs | Not available in current plan. . | Book a free demo | ||
Sales 4: Regulatory requirements | Not available in current plan. . | Book a free demo | ||
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QM system: Infrastructure | |||
Infrastructure: Part 1 Introduction | Not available in current plan. . | Book a free demo | ||
Infrastructure: Part 2 Requirements | Not available in current plan. . | Book a free demo | ||
Infrastructure: Part 3 Maintenance activities and documentation | Not available in current plan. . | Book a free demo | ||
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QM system: Measuring equipment | |||
Measuring equipment 1: Introduction | Not available in current plan. . | Book a free demo | ||
Measuring equipment 2: Regulatory requirements 13485 (overview) | Not available in current plan. . | Book a free demo | ||
Measuring equipment 3: Regulatory requirements 13485 (7.6 - Part 2 - Measuring equipment) | Not available in current plan. . | Book a free demo | ||
Measuring equipment 4: Regulatory requirements 13485 (7.6. - Part 3 - Software) | Not available in current plan. . | Book a free demo | ||
Measuring equipment 5: Regulatory requirements 13485 (procedure instruction) | Not available in current plan. . | Book a free demo |
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:
Name | Watched | Assessments | ||
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Introduction | Not available in current plan. . | Book a free demo | ||
Regulations | Not available in current plan. . | Book a free demo | ||
Obligation to have a PRRC | Not available in current plan. . | Book a free demo | ||
Qualification | Not available in current plan. . | Book a free demo | ||
Responsibilities (overview) | Not available in current plan. . | Book a free demo | ||
Product release | Not available in current plan. . | Book a free demo | ||
Technical Documentation | Not available in current plan. . | Book a free demo | ||
Post Market Surveillance | Not available in current plan. . | Book a free demo | ||
Vigilance, Reporting 1 | Not available in current plan. . | Book a free demo | ||
Vigilance, Reporting 2 | Not available in current plan. . | Book a free demo | ||
Investigational devices | Not available in current plan. . | Book a free demo | ||
Finding PRRC | Not available in current plan. . | Book a free demo |
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:
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:
Name | Watched | Assessments | ||
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Introduction | Not available in current plan. . | Book a free demo | ||
Basics | Not available in current plan. . | Book a free demo | ||
Product categories | Not available in current plan. . | Book a free demo | ||
Basic UDI-DI | Not available in current plan. . | Book a free demo | ||
Regulatory requirements | Not available in current plan. . | Book a free demo | ||
Allocation and assignment of UDI | Not available in current plan. . | Book a free demo | ||
GS1 | Not available in current plan. . | Book a free demo | ||
HIBCC | Not available in current plan. . | Book a free demo | ||
UDI carrier | Not available in current plan. . | Book a free demo | ||
Application | Not available in current plan. . | Book a free demo | ||
Implants | Not available in current plan. . | Book a free demo | ||
Systems and procedure packs | Not available in current plan. . | Book a free demo | ||
IVDR | Not available in current plan. . | Book a free demo | ||
Configurable products | Not available in current plan. . | Book a free demo | ||
UDI and Software | Not available in current plan. . | Book a free demo | ||
New UDI | Not available in current plan. . | Book a free demo | ||
EUDAMED | Not available in current plan. . | Book a free demo | ||
FDA differences | Not available in current plan. . | Book a free demo | ||
Transition periods | Not available in current plan. . | Book a free demo |
Your software file demonstrates that you meet the legal requirements for medical device software lifecycle processes. A typical software file includes:
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:
Clinical evaluation is required by law.
In this course, you will learn:
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.
Name | Watched | Assessments | ||
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Welcome | Not available in current plan. . | Book a free demo | ||
Scope | Not available in current plan. . | Book a free demo | ||
Chapter 2 | Not available in current plan. . | Book a free demo | ||
Annex I, Part 1 | Not available in current plan. . | Book a free demo | ||
Annex-I Software | Not available in current plan. . | Book a free demo | ||
Annex II | Not available in current plan. . | Book a free demo | ||
Classification | Not available in current plan. . | Book a free demo | ||
Conformity Assessment | Not available in current plan. . | Book a free demo | ||
Quality Management System | Not available in current plan. . | Book a free demo | ||
Post Market Surveillance | Not available in current plan. . | Book a free demo | ||
Roles | Not available in current plan. . | Book a free demo | ||
PLM-OEM | Not available in current plan. . | Book a free demo |
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:
Name | Assessments | ||
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ISO 10993-1 and Biocompatibility - Material Certificates Are Not Enough! | Not available in current plan. . | Book a free demo | |
Cytotoxicity Testing According to EN ISO 10993-5: Avoiding Pitfalls When Choosing a Laboratory | Not available in current plan. . | Book a free demo | |
No animal testing to prove biocompatibility | Not available in current plan. . | Book a free demo | |
EN ISO 18562: Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications | Not available in current plan. . | Book a free demo | |
ISO 17664-1 – Information on Processing of Medical Devices | Not available in current plan. . | Book a free demo |
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:
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.
Name | Assessments | ||
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Your path to FDA approval: 1st Sprint | Not available in current plan. . | Book a free demo | |
Your path to FDA approval: 2nd sprint | Not available in current plan. . | Book a free demo |
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