Strategies for Successful PMCF under EU MDR: Unlocking the Mystery – Webinar in partnership with Medtech Intelligence

• What: Webinar in coordination with Medtech Intelligence – “Strategies for Successful PMCF under EU MDR: Unlocking the Mystery”
• When: March 6th, 2024, 10:00 am – 11:00 am EST
• Where: Online Event
• How: Register Here – this webinar will include a 45-minute presentation and 10 to 15 minutes of Q&A.
• Why: Join our upcoming interactive webinar on Post-Market Clinical Follow-up (PMCF) as we delve into understanding the essence of PMCF

Unlock the secrets to cost-effective PMCF strategies and conquer Notified Body comments. In the dynamic landscape of the European Medical Device Regulation (MDR), mastering PMCF is imperative for sustained compliance and product excellence. This webinar goes beyond theory, delving into real-world case studies that spotlight successful PMCF implementations, providing actionable insights and lessons. Don’t miss this opportunity to refine your approach to PMCF and ensure compliance while optimizing product performance in the market.

This featured presentation will be led by Celegence’s Smridula Hariharan, Manager – Medical Device Services and Parvathi Nambiar, Team Lead – Medical Device Services. Our panelists will also be available for a live Q&A session after the presentation.

Have a question now? Submit it ahead of time and we will endeavor to provide you with a live answer during our webinar, submit your question here.

Celegence will be hosting the Webinar on Wednesday, March 6, 2024, 10:00 am ET. Register online now!

1. Smridula Hariharan, Manager, Medical Device Services, Celegence

Smridula Hariharan has a master’s degree in pharmacology, and over 12 years of experience in Medical Writing for Medical Device Regulatory Affairs as well as pharmacovigilance and clinical research. She has authored and reviewed post-market surveillance (PMS) documents for medical devices and invitro diagnostics belonging to different risk classes and therapeutic areas.

She has successfully procured CE marking under MDD and MDR for novel as well as legacy products through comprehensive clinical evaluations, PMS plans, and PMCF plans/reports. She has also been involved in authoring and reviewing safety narratives, Clinical Investigation Plans (CIP), Clinical Study Reports (CSR), and developing SOPs and templates for a variety of PMS documentation.

At Celegence, she leads a team of medical writers who work on CEPs, CERs, PMS Plan, Post-Market Surveillance Reports, Periodic Safety Update Reports, Post-Market Clinical Follow-up Plan and Reports, for devices spanning a wide range of therapeutic areas including cardiology (stents/ defibrillators/ valves/ guidewires/ catheters), dentistry (implants/screws/ cements, attachments/ abutments, kits as well as single products), radiosurgery, diagnostic imaging, in vitro fertilization (IVF), female health products, bandages/sutures/wraps, airway monitoring, BP apparatus, thermometers (digital and mercury), nephrology products (dialysis units and all its related accessories).

2. Parvathi Nambiar, Team Lead, Medical Device Services, Celegence

Parvathi has a master’s degree in microbiology, and an overall 6 years of experience in Medical Writing for Pharma and Medical Device Regulatory Affairs. She has authored and reviewed post-market surveillance (PMS) documents and Clinical Investigation Plan (CIP) and Clinical Study Report (CSR).

At Celegence, she leads a team of medical writers who work on CEPs, CERs, PMS Plan, Post-Market Surveillance Reports, Periodic Safety Update Reports, Post-Market Clinical Follow-up Plan and Reports, for devices belonging to a wide range of therapeutic areas including all specialties of dentistry, radiosurgery, diagnostic imaging, in vitro fertilization (IVF)/assisted reproductive technology (ART) devices, cardiac defibrillator, and female health products.

She has also worked on successfully addressing notified body comments received on PMS documents.

• Understanding the Regulatory Landscape: Gain a comprehensive understanding of the European Medical Device Regulation (MDR) and its implications on Post-Market Clinical Follow-Up (PMCF) requirements. Explore the key components and essential elements of a robust PMCF plan, ensuring compliance with EU MDR guidelines.
• Effective Data Collection Strategies: Learn practical and efficient strategies for collecting relevant post-market clinical data, ensuring it aligns with regulatory requirements while optimizing resources.
• Cost-Effective Compliance Solutions: Discover practical approaches and best practices for achieving cost-effective PMCF processes that meet regulatory standards, minimizing financial impact while ensuring ongoing compliance with EU MDR.
• Case Study Analysis: Examine real-world case studies illustrating successful Post-Market Clinical Follow-Up (PMCF) strategies, providing insights into challenges, solutions, and best practices.
• Notified Body Observations Deconstructed: Understand common observations and feedback from Notified Bodies regarding PMCF, dissecting these insights to enhance your approach and proactively address potential issues.

The webinar is intended for professionals of the medical device industry: Personnel of Clinical Affairs, Regulatory Affairs, Quality Management and others involved in the Clinical Evaluation/Performance Evaluation. This webinar is perfect for Top Management / VPs, R&D Managers, Medical Device Executives, Technical Writers and Managers and Medical Writers / Reviewers.

As a global regulatory solutions and services provider, Celegence can support your organization with EU MDR Gap Analysis, PMS Reporting, Clinical Documentation and Notified Body Interactions to achieve maximum compliance, save time and improve operational efficiency. Now is the time to start adoption of technologies like CAPTIS™, our groundbreaking EU MDR & IVDR solution which increases efficiency of medical writers to ensure ongoing, sustained compliance.

“Strategies for Successful PMCF under EU MDR: Unlocking the Mystery” webinar will be held on Wednesday, March 6th at 10:00 AM ET. Make sure you secure your spot at the webinar by registering now.

We are happy to share our insights with you through the webinar with Medtech Intelligence. For more information on how Celegence can help you with EU MDR and IVDR requirements, reach out to us at info@celegence.com, contact us online or read more about Celegence’s services.