The new IVDR will affect all In Vitro Diagnostic manufacturers. Scope & plan, GAP-Assessment, notified body selection, and Conformity Assessment are just some of the steps to take for IVDR Implementation that must be addressed to ensure compliance.
There is an enormous amount of work required to transition from IVDD to the IVDR IN 2022, manufacturers need to recognize that the IVDR is more complex and detailed and will, therefore, require more resources to maintain as well as implement.
Qserve has designed a 5-session training program to assist in determining the crucial steps needed for your organization. These training sessions will provide the opportunity to interact, network and discuss your organizations ‘challenges.
There are two options to participate in the program: through the open enrollment sessions in London/ Frankfurt or follow the Virtual sessions (US time). We offer flexible options for your company, team, or individual experts. You can send different experts from your company to the sessions and still qualify for the package and you can choose from the dates and locations (London, Frankfurt or Virtual).
Note: In the Virtual program you will have a web-based training per subject and then there is an optional in-house workshop to discuss your own documents.
Training Courses and workshops in London/ Frankfurt
The following Training Courses and workshops are available to be followed in London and Frankfurt:
- IVDR Fundamentals and how to work with a Notified Body (1 day)
- Technical Documentation and Clinical Evidence for existing devices (2 days)
- Risk Management to meet the IVDR (1 day)
- IVDR PMS and PMPF and how to implement them requirements (1 day)
- Preparing the QMS for the IVDR (1 day)
Pricing for the London/Frankfurt Training Courses:
- 1 Day training - € 875.-
- 2 Days training (Technical Documentation) - € 1750.-
- 5 Training courses pass including workshops - € 3900.-
If you would like to register for the 5 training courses pass, please send an email to Registration
Virtual Training Courses
The following Virtual Training Courses are available:
- a. IVDR Fundamentals (90 min)
b. How to work with a Notified Body (90 min)
- a. Technical Documentation (90 min)
b. Clinical Evidence for existing devices (90 min)
- Risk Management to meet the IVDR (90 min)
- IVDR PMS and PMPF and how to implement them requirements (90 min)
- Preparing the QMS for the IVDR (90 min)
Pricing for the Virtual Training Courses:
- 1 Virtual Training - € 700.- / $ 790.-
- 5 Virtual Training courses - € 2500.- / $ 2825.-
- Tailored workshop: price on application