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knoell Germany GmbH

Konrad-Zuse-Ring 25, 68163 Mannheim
Germany
Telephone +49 621 718858-0
Fax +49 621 718858-100
MedDev@knoell.com

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Contact

Dr. med. Isabelle Lang-Zwosta

Global Regulatory Affairs Manager
knoell Medical Devices LLC (Nashville, TN)

Phone
+1 615 374 1242

Email
ILang-Zwosta@knoell.com

Maik Endler

Managing Director
knoell Brazil (São Paulo)

Phone
+55 11 97053 3040

Email
MEndler@knoell.com

Dr. rer. nat. Peggy Synwoldt

Medical Device Consultant
knoell Germany GmbH (Berlin)

Phone
+49 30 2000357-27

Email
PSynwoldt@knoell.com

Camila Campos Santos

Regulatory Affairs Manager, Medical Devices
knoell Brazil (São Paulo)

Phone
+55 11 97060-6022

Email
CCampossantos@knoell.com

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16 Nov 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

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18 Nov 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

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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. 

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About us

Company portrait

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

Company data

Number of employees 500-999
Foundation 1996
Area of business Services