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In a dynamic company, new employees are hired and existing employees change positions. In the meantime, regulations and standards evolve and customers’ expectations keep rising. To support internal growth and change and to stay competitive in a changing environment, organizations face continuous training needs.

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

Advantages

Qarad’s training is characterized by:

  • A focus on practical implementation.
  • Trainers with many years experience in the field.
  • Trainees who go home with templates, checklists and other tools ready to be use in their own company.
  • Official training certificates

Training sessions

Qarad offers practical training via:

  • In-house training sessions at your company’s site
  • Webinars

 

These training sessions are specifically designed for the Quality Assurance and Regulatory Affairs in the IVD and Medical Devices field.

Alternatively, Qarad also offers ready-to-use tools and templates that can immediately be used in your own company.

Moreover, we are organizing our 6th annual Qarad IVDR Conference, where we will highlight a lot of new information based on our experience and focus on new guidance documents.

Training topics

European Directive 98/79/EC on In Vitro Diagnostic Medical Devices

In-depth training course on all aspects of the Directive, including the business implications.

European Regulation 2017/746 on In Vitro Diagnostic Medical Devices

Focus on the new requirements of the IVDR and why and how it will affect your business and your processes.

ISO 13485: the Quality System Standard

The structure and requirements of the ISO13485:2016 standard and which requirements you should consider to setup your QMS.

Quality Awareness

What is quality and why is it important?

Risk Management and Analysis

The Role of risk management in regulations, according to the harmonized standard ISO14971.

Process Approach

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

Internal Auditing

Tips and tricks to become a good internal auditor.

Design Control and Product Development Process

How to establish an efficient and compliant product development process?

Technical Documentation and Conformity Assessment

How to establish and document that your IVD products comply with the different requirements?

Trainees can immediately use Qarad’s practical tips and tricks in their own company.

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