2nd IVDR & Immunoassays Mini Symposium
Future Diagnostics is proud to be organizing our second IVDR & Immunoassays Mini Symposium on Wednesday November 20th, 2019 from 9 am to 10.30 am during MEDICA. Register below to reserve your seat.
Surely you have heard about it: the IVDR, the new In Vitro Diagnostic Medical Devices Regulation. Published in May 2017, it replaces the In Vitro Diagnostic Medical Devices Directive (IVDD) and brings new requirements for manufacturers. The good news is: there is a five-year transition period. But do you know how this affects you, and how you will make sure you are fully compliant by 2022?
Agenda:
9.00: “Quality/Regulatory Interactions between Legal and Contract Manufacturer” by Dr. Maurizio Suppo, Qarad (Consulting, Performance Evaluation and Autorized Representative Services)|
9.25: “Proper Design Control as per the IVD-R requirements” by Dr. Maurizio Suppo
9.50: “Transition to IVDR: Experiences from an assay developer in practice“ by Dr. Mike Martens, Future Diagnostics Solutions (Scientific Business Executive)
10.15: Panel Discussions led by Danielle Malkowski-Nillesen, Future Diagnostics Solutions (International Business Development)
With the IVDR we will see many changes in definitions, and it also has a wider scope. This means that products currently classified as an in vitro diagnostics device (IVDD), may require IVDR compliance. The IVDR also tightens the requirements for clinical evidence and conformity assessment. Technical documentation must contain the results and critical analyses of all design verification and validation tests – data must be collected in compliance with the harmonised standards and applicable Common Specifications.
Where?
Messe Düsseldorf, Germany
Location: Room 28 (entrance Süd, above Hall 3)
When?
Wednesday November 20th, 2019: 9 am to 10.30 am
Costs?
Free of Charge