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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 |
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:
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:
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:
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.
Name | Watched | Assessments | ||
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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 | ||
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 | ||
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 | ||
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 | ||
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 | ||
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 | ||
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 | ||
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 | ||
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 | ||
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 | ||
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 | ||
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 | ||
QM-System: Process Validation | ||||
Process Validation 1: Basics | Not available in current plan. . | Book a free demo | ||
Process validation 02: IQ, PQ, OQ | Not available in current plan. . | Book a free demo | ||
Process validation 3: regulations | Not available in current plan. . | Book a free demo | ||
QM-System: Storage and Transport | ||||
Storage & Transport 01: Introduction | Not available in current plan. . | Book a free demo | ||
Storage & Transport 02: Measures | Not available in current plan. . | Book a free demo | ||
Storage & Transport 3: Risk Management | Not available in current plan. . | Book a free demo | ||
Storage & Transport 04: Regulations | Not available in current plan. . | Book a free demo | ||
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 | ||
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 | ||
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 |