Unveiling Impactful Methods to Strengthen Device Claims – Webinar

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 19^that 10 am CT. Register online now!

• 9 Years of medical writing experience including medical devices and In vitro diagnostics. Experience spanning different therapeutic areas and all the different risk classes of devices.
• Authored and reviewed several Scientific Validity reports (SVR), Clinical performance reports (CPR), Analytical performance reports (APR), Performance evaluation plans (PEP) and Performance evaluation reports (PERs) for in vitro diagnostics in compliance with IVDR.
• Authored and reviewed several Clinical evaluation plans (CEPs), Clinical evaluation Reports (CER), PMS plans and reports, Periodic safety update reports (PSUR), Summary of Safety and Clinical performance (SSCP), Post market clinical performance plans and reports (PMCF), both MDD and MDR compliant.
• Developed SOPs for PMS activities/ documents and templates for CEPs, CERs, SVRs, CPRs, PEP, PERs, PMS and PMCF plans and Reports in compliance with MDR and IVDR requirements.
• Consults on responses and CAPAs to be implemented for NB queries and Major and minor non-conformities raised for CERs and PERs.

• Clear outline of the relation between clinical benefit and intended purpose
• Overcoming common pitfalls with:
  • Identifying clinical safety and performance claims
  • Associated measurable clinical benefits
  • Defining end-points to support claims and benefits
• Surrogate endpoints for GSPR conformity
• Lessons from frequent notified body queries
• Focus on useful quantity and quality of data

• Hear the key insights and best regulatory approach into the best practices to determining measurable device claims
• Examine examples and relevant case studies on the type of notified body comments and queries regarding the claims/ benefits cited in the CEP and CER
• Have your most pressing questions answered during the Q/A session

This webinar is aimed towards those working for companies in the life sciences industry, particularly manufacturers of medical devices, with a special emphasis on:

• Regulatory Affairs Professionals
• Quality Assurance Professionals
• Medical Device Executives
• Technical Writers and Managers
• Medical Device Design Managers
• Clinical Managers

“Unveiling Impactful Methods to Strengthen Device Claims” webinar will be held on July 19th, 2022, from 10:00 am – 11 am CT. Make sure you secure your place at the webinar by registering now.

Celegence provides the medical device industry with consulting services that are tailored to the evolving needs of manufacturers. Our suite of services including EU MDR related support allows you to focus on your core responsibilities. With our guidance, bringing your devices to the market and keeping them there will be easier for your regulatory and quality teams.

For more information on how we can help you with EU MDR requirements reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device services.