Webinar
Medical Devices

Preparing a Clinical Evaluation Report (part 2)

Understand how best to document clinical investigations, including expectations around supporting documentation related to clinical investigations.

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In this Webinar:

Documenting Clinical Investigations.
Stratification of Data & Analysis.
Considering data in special & difficult situations.
Benefit-Risk Assessment.

Speakers

Hear from the experts in this webinar

Speaker

Richard Holborow

Head of Clinical Compliance, BSI

Speaker

Sheila Walsh

Clinical Regulatory Lead, Clinical Compliance Team, BSI

More webinars in the 2023 Clinical Masterclass Series

Ensure your product maintains EU market access under the new, more stringent Medical Device Regulations (MDR).

Performing a robust clinical evaluation plan is a critically important step and if not done correctly can undermine your overall clinical evaluation.

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Preparing a good quality clinical evaluation report for submission to the notified body is vital to ensure they understand your device.

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This webinar will focus on how best to document PMCF plans and evaluation reports.

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The summary of safety and clinical performance (SSCP) is a new requirement under the MDR.

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Insights & Media

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Unlocking the Potential of Consumer Wearables in Healthcare

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Symbols & Details Required for Medical Devices & IVDs

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Annex XVI - Devices Without an Intended Medical Purpose

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