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Complimentary Webinar
March 6, 2024|10:00 AM ET (US)| 15:00 UTC

Strategies for Successful PMCF under EU MDR: Unlocking the Mystery

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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."

YOU'LL LEARN : 

  • 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.

WHO SHOULD ATTEND:

  • Medical Device Manufacturers
  • Top management / VPs
  • R&D managers
  • Regulatory Affairs Professionals
  • Quality Assurance Professionals
  • Medical Device Executives
  • Technical Writers and Managers
  • Medical Writers / Reviewers
  • Medical Device Executives
  • Clinical Managers

SPEAKERS

Smridula Hariharan

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).

Parvathi Nambiar

Parvathi Nambiar
Team Lead, Medical Device Services
Celegence

Parvathi Nambiar has a Master’s degree in Microbiology, and over 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.

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