All trainings on IVDR compliance
1 day customized training | Practical guidance to implement IVDR from determining the gaps from your current documentation and processes and the IVDR requirements.
6 customized training sessions on IVDR implementation | The sessions can be tailormade to your product portfolio and can be focused on your situation as a start-up or a company transitioning to the IVDR.
The new structure and revised scope of the IVD, the classification rules, technical documentation changes and Post Market surveillance.
What will change? What to expect in unannounced audits? Internal audits and IVDR readiness.
How to get started, preparing and compiling technical files, what are the requirements and keeping the file up to date.
How to select and work with Notified Body's (NB's / NoBo's) effectively.
Understand the key concepts of risk management and how to use ISO 14971 to meet the IVDR.
Learn the PMS and PMPF requirements, how to prepare plans and repost and implementation for existing devices.
Understand the requirements for the IVDR, including the intended purpose, Scientific Validity and literature searches, Analytical and Clinical Performance.
Manufacturers and Authorized representatives need to appoint a Person Responsible for Regulatory Compliance (PRRC) within the IVDR and MDR.