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