Join a webinar or choose for an in-company training session
More specific information about each of Qarad’s basic training topics
In-depth training course on all aspects of the Directive, including the business implications.
Part of the program covers general management and commercial functions; another part 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
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
International standard ISO13485:2016 specifies which requirements an organization should consider to set up 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 set up, building the framework of a quality management system and using the system in daily operations.
Course material: PowerPoint hand-outs, document tables
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
The role of quality systems in regulations and legislation.
Course material: PowerPoint presentation hand-outs
Implementation of risk management in practice: a hands-on exercise with 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).
Product development is a complicated process.
Interactive training session with your company as the basis for practical exercises.
Course material: PowerPoint hand-outs , templates and procedures
Practical exercise with a process in your company.
Course material: PowerPoint hand-outs
Includes a practical exercise.
Course material: PowerPoint hand-outs, checklists and templates