Module 18 2021

2/9/2021

Clinical Evidence & Evaluations

Richard Holborow Head of Clinical Compliance 8 th February 2021

Copyright © 2020 BSI. All rights reserved

Copyright © 2020 BSI. All rights reserved

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Contents  A few terms and definitions  When do we need Clinical Evidence?  Defining State of the Art  Equivalence

 Types of Evidence & Considerations  MDR documentation requirements  Maintaining and updating the clinical evaluation

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Copyright © 2020 BSI. All rights reserved

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