What: Webinar – “Unveiling Impactful Methods to Strengthen Device Claims”
When: Tuesday, July 19th 2022 at 10 am CT
Where: Online Event
How: Register Here
Why: Join us to examine the best practices to determine measurable claims, identifying clinical endpoints or surrogate endpoints, to demonstrate conformity with General Safety and Performance Requirements (GSPRs) for MDR compliance.
Clinical benefit means:
“the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health”.
The type of clinical benefit associated with a device depends upon the device under evaluation and its intended purpose.
One of the major hurdles faced by manufacturers while creating MDR compliant CERs is identifying clinical safety and clinical performance claims and their associated measurable clinical benefits. Another hurdle is defining the end points that can be used to establish that the device in fact achieves these claims and benefits. There are several considerations when determining the claims and their end points.
This featured presentation will be led by Celegence’s Medical Device RA Expert, Smridula Hariharan. In this session you will hear key insights into the best practices to determining measurable claims, identifying clinical endpoints or surrogate endpoints to demonstrate conformity with the GSPRs. Smridula will also be available after the presentation for a live Q/A session.
Celegence will be hosting the WEBINAR on Tuesday, July 19that 10 am CT. Register online now!