Training

In a dynamic company, new employees are hired and existing employees change positions. In the mean time, regulations and standards evolve and customers’ expectations keep rising. To support internal growth and changes, and to stay competitive in a changing environment, each organization is facing continuous training needs.

Qarad has established a series of training modules, mostly in the field of Quality Assurance and Regulatory Affairs.
Training sessions can be organized in your company, in our own offices or in another place of your choice, anywhere in the world.

Qarad training sessions are interactive and driven towards practical implementation and application. Qarad trainers are experienced in what they teach, know the practical problems to be encountered and provide real solutions for your company.

Training courses are given in English, Dutch and French. Course material is in English.
Training certificates are issued to the participants.

Contact us for a price quotation.

Training module

Quality awareness training

Risk management and analysis training

Process approach training
 

Internal auditing training

European Directive 98/79/EC for IVD training
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ISO13485 for MD and IVD Training Product development process training Technical documentation and_conformity assessment for IVD training

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

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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 analysis 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 analysis: CD-ROM and manual for doing risk analysis, including templates and examples.

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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

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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

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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)

The publication of the European Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) in May 2017, was the start of a 5 year transition period for a significant regulatory overhaul. The new regulatory regime for IVDs introduces a new classification system, new conformity assessment routes with the majority of products requiring Notified Body review, new extended clinical evidence requirements, and many more.

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.

Contact us for more detailed information.

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

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ISO13485: the quality system standard for manufacturers of medical devices and in vitro diagnostic medical devices (0.5 or 1 day)

ISO13485 vs. ISO9001: what are the differences? How to achieve compliance?

Course material: PowerPoint hand-outs, cross-reference tables 

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Product development: how to establish an efficient and compliant 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 

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Practical training: establishing Technical Documentation and executing Conformity Assessment in the context of Directive 98/79/EC on in vitro diagnostic medical devices (1 day)

How to establish and document that your IVD products meet the Essential Requirements and 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, CD-ROM and manual: checklists and technical documentation organization

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Training
« Thanks to your pleasant and professional coaching of our team, you had an essential role in our ISO certification. »

MCA Research Laboratory Ltd.
« Very thorough knowledge of content. »

OraSure Technologies, Inc.
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