Qarad trainings

The European Directive 98/79/EC on in vitro diagnostic medical devices

0.5 or 1 day

In-depth training course on all aspects of the Directive, including the business implications.
A part of the program can be directed to general management and commercial functions.
Another part of the program covers the consequences for R&D, Quality Assurance, Regulatory Affairs, Manufacturing, etc…

The program can be reduced to half a day, for example for companies who are not manufacturing and/or developing products.

Course material: PowerPoint hand-outs, copy of the IVD Directive

The European Regulation 2017/746 on in vitro diagnostic medical devices

0.5 or 1 day

For companies subject to the change a key step is to gain understanding of what is changing, why and how it will affect their business and processes.

A key to a successful project implementation is ensuring everyone affected by the change understands what is happening and why the company will be making the changes (change management).

Qarad offers tailor-made IVDR training courses, ranging from basic introduction training to in-depth subject specific courses tailored to your company needs. We can support you in gaining buy in from your stakeholders and in making your IVDR projects a success by training members of all levels, to help guide them through the change.

Course material: PowerPoint hand-outs, copy of the IVD Regulation

ISO13485: the quality system standard for medical devices and in vitro diagnostic medical devices

0.5 or 1 day

International standard ISO 13485:2016 specifies which requirements an organization should consider to setup a Quality system.

This training will explain the structure and requirements in the ISO13485:2016 standard.

You will understand the interaction of processes needed, how documentation can effectively be setup, building the framework of a quality management system and using the system in daily operations.

Course material: PowerPoint hand-outs, document tables

Internal auditing in practice

1 day

• How should the internal auditor behave?
• What skills does he need?
• How to set up an internal auditing program in practice and how to integrate in your quality system?

Includes a practical exercise in your company.

Note: the trainees should have a basic understanding of the quality system standard or regulation concerned.
If this is not the case, an additional half day or full day of introduction to this standard or regulation is recommended.Course material: PowerPoint hand-outs, templates and tools

Quality awareness training

0.5 day

• What is quality and why is it important?
• What is a quality system and how does it help in achieving quality?
• Why do you need a quality system?

The role of quality systems in regulations and legislation.

Course material: PowerPoint presentation hand-outs

Risk management and risk analysis for medical devices and in vitro diagnostic medical devices

1 day

• Role of risk management in regulations.
• The harmonized standard ISO14971.

Implementation of risk management in practice: hands-on exercise on a product of your company, using Qarad’s Roadmap as a guide and FMEA as a methodology.

Course material: PowerPoint presentation hand-outs. Qarad’s Roadmap for risk assessment: manual, templates and tools.

Design Control and the Product development process

1 day

Product development is a complicated process.

• How to integrate requirements from regulations, customers and your company itself in the development process?
• How to ensure that all design output is available at the right time? How to achieve compliance with regulations?

Interactive training session with your company as the basis for practical exercises.

Course material: PowerPoint hand-outs , templates and procedures

The “Process Approach” in practice

0.5 day

• How to describe a process for ISO compliance?
• How to measure and monitor process performance?

Practical exercise on a process in your company.

Course material: PowerPoint hand-outs

Practical training: establishing Technical Documentation and executing Conformity Assessment in the context of IVDD or IVDR

1 day

• How to establish and document that your IVD products meet the Essential Requirements (under the IVD-D) or General Safety and Performance Requirements (under the IVD-R)
• How to meet the requirements of harmonized standards?
• How to organize in a practical and efficient way your Technical Documentation?

Includes a practical exercise.

Course material: PowerPoint hand-outs, checklists and templates