Training
From IVDD to IVDR
Although there are some transitional arrangements, from 26 May 2022 manufacturers of In Vitro diagnostic medical devices have to meet the requirements of the new IVDR. The IVDR will replace the IVDD, EU's In Vitro Diagnostics Directive (98/79/EC) as the legislation detailing the requirements that manufacturers have to meet to place in vitro diagnostics on the market in the European Union.
There is a enormous amount of work required to transition from the IVDD to the IVDR, 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 6-session virtual training program to assist manufacturers in determining the crucial steps needed for your organization. Theses training sessions will provide the opportunity to interact, network and discuss your organizations' challenges. It is also possible to attend only one training by choice.
Program Overview
Duration: 6 training sessions of +/- 2 hours each (virtual or in-house, to be determined in consultation)
It is also possible to attend only one training by choice.
Learning Objectives
The different sessions will present participating organizations the opportunity to prepare their subject matter experts, thus, employees will be trained on the implementation process in their specific area of expertise.
- Interpreting the requirements
- What are the requirements and what are the expectations?
- What data do you need and what sources can you use for new and existing devices?
- Creating files that are easy to review
Who should attend?
The program includes exclusive content developed by Qserve's experts and is suitable for professionals at any level of knowledge (beginner to advanced professional).
- Senior Management
- Regulatory Affairs Managers, Quality Managers and/or Directors
- Clinical Affairs
- R&D, Product Development, Manufacturer, Operations and Marketing Managers
- International registration department
You can send different experts from your company to the sessions and still qualify for the package.
Costs
Price on application for customized trainings, tailored workshops, on-location training, train-the-trainer formats or multiple training courses
Team Members with different roles and responsibilities? We offer flexible options for your company, team, or individual experts. You can send different delegates from your company to the sessions and still qualify for the package.