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Brazilian certification - how to effectively interact with laboratories and Brazilian agencies
When attempting the Brazilian market it is crucial to understand and effectively interact with the local regulators and testing laboratories. We help you understand the country specific roles and responsibilities, show you based on real world examples what pitfalls might be just around the corner and thus allowing you to get the best possible start for this fantastic market.
Presenter: Camila Campos Santos (Bachelor of Biomedical Engineering), knoell Brazil, Health Care - Medical Devices, Regulatory Affairs Manager
Best practice for implementing the performance evaluation requirements for IVDs under EU IVDR
The presentation will handle the new regulatory requirements to performance evaluation for IVDs according to IVDR (EU) 2017/745 and provide best practice solutions for its implementation. In detail: - Regulatory changes for all four IVD risk classes - Decision advice for performance evaluation strategy (e.g. clinical studies needed) - Advice for creating the performance plans and reports
Presenter: Dr. ret. nat. Peggy Synwoldt, knoell Germany GmbH, Health Care - Medical Devices, Medical Device Consultant
Our experts help manufacturers of Medical Devices and IVDs to effectively navigate the brazilian regulatory landscape. Also, don't miss the web session of our fabulous Camila Campos Santos on the basics of Brazilian Certifications on Monday, November 16th.
Founded in 1996, knoell is a leading provider of global regulatory services and risk assessments for market segments related to biocides, chemicals, cosmetics, crop protection, food contact materials, medical devices and veterinary medicine. We support our clients in all phases of the registration process, from planning right through to market launch and beyond. For medical devices and in-vitro diagnostic medical devices, we support with e.g. designing quality management systems, technical documentation, preparation of biocompatibility evaluations and toxicological reports. We conduct training courses and audits and help with the implementation of development and production processes. For further information please visit https://www.knoell.com/en/business-units/medical-devices