Preparing a Summary of Safety and Clinical Performance (SSCP)

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

In this Webinar:

Speakers

Speaker

Clinical Regulatory Lead, Clinical Compliance Team, BSI

Speaker

Head of Clinical Compliance, BSI

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

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

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