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knoell Germany GmbH
Konrad-Zuse-Ring 25,
68163
Mannheim
Germany
Germany
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Contact
Dr. med. Isabelle Lang-Zwosta
Global Regulatory Affairs Manager
knoell Medical Devices LLC (Nashville, TN)
knoell Medical Devices LLC (Nashville, TN)
Maik Endler
Managing Director
knoell Brazil (São Paulo)
knoell Brazil (São Paulo)
Dr. rer. nat. Peggy Synwoldt
Medical Device Consultant
knoell Germany GmbH (Berlin)
knoell Germany GmbH (Berlin)
Camila Campos Santos
Regulatory Affairs Manager, Medical Devices
knoell Brazil (São Paulo)
knoell Brazil (São Paulo)
Visit us
16.11.2020
Topic
14:00 - 14:30
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
Please visit: https://events.medica.de
Presenter: Camila Campos Santos (Bachelor of Biomedical Engineering), knoell Brazil, Health Care - Medical Devices, Regulatory Affairs Manager
Please visit: https://events.medica.de
18.11.2020
Topic
13:20 - 13:50
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
Please visit: https://events.medica.de
- 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
Please visit: https://events.medica.de
Our range of products
Product categories
- 03 Services
- 03.02 Consulting (services)
- 03.02.01 Market access, internationalization
Market access, internationalization
- 03 Services
- 03.02 Consulting (services)
- 03.02.04 Regulatory affairs
Regulatory affairs
- 03 Services
- 03.02 Consulting (services)
- 03.02.07 Medical device approval
Medical device approval
- 03 Services
- 03.04 Design and development
- 03.04.01 Product design, product development
Product design, product development
- 09 Software, IT
- 09.04 Software as medical product
Software as medical product
Our products
Product category: Market access, internationalization
Regulatory Support for Brazilian market access
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.
About us
Company details
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
For further information please visit https://www.knoell.com/en/business-units/medical-devices
Company data
Number of employees500-999
Foundation1996
Area of businessServices