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Complimentary Webinar
April 24, 2024|10:00 AM ET (US)| 15:00 UTC

Mastering Compliance: Essential Insights into PMS Documentation

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Explore and understand the critical elements of PMS documentation and empower yourselves with effective strategies to navigate its complexities. In this webinar, we will delve into the significance of PMS documentation for medical devices, offering invaluable insights on ensuring compliance with regulatory requirements. Whether you are a regulatory affairs specialist, quality assurance professional, or involved in product development, this webinar promises to equip you with the knowledge needed to enhance your organization's PMS documentation processes. Don't miss this opportunity to stay ahead of the curve in the ever-evolving landscape of medical device compliance.

YOU'LL LEARN : 

• Understand the Essential Components: Learn the essential components of PMS documentation and their importance. Gain insights into the significance of PMS documentation in ensuring compliance with regulatory requirements.

• Master Effective Data Collection Strategies: Uncover the multitude of internal and external data sources vital for robust PMS documentation. Develop effective techniques for collecting, analyzing, and presenting data in your PMS documentation.

• Leverage Technology for Enhanced Precision and Productivity: Establish and execute a thorough protocol for systematic literature reviews using technology. Harness the power of technology to elevate accuracy and efficiency in your regulatory compliance processes.

• Strategize PMCF pathway: Understand the role of PMCF as part of PMS documentation and how to strategize cost-effective and successful PMCF pathways.

• Navigate Observations from Notified Body: Identify common observations, feedback from Notified Bodies, and implement best practices to proactively address the key areas for increased chances of regulatory compliance.

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

Dr. Kasturi Rao
Team Lead, Medical Device Services
Celegence

Kasturi Rao holds a Doctor of Philosophy (Ph.D.) degree in Cancer Research. She has 11 years of overall experience in medical device regulatory affairs and scientific writing. She has authored and reviewed various critical documents such as Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS) documentation, Post-Market Clinical Follow-up (PMCF) reports, and Summary of Safety and Clinical Performance (SSCP) documents for medical devices. These documents adhere to EU Medical Device Regulation (MDR) and MEDDEV 2.7/1 Rev 4 guidelines, ensuring compliance and quality.
Kasturi Rao has extensive experience in handling end-to-end Post-Market Surveillance (PMS) documentation. This includes conducting literature reviews for Device under Evaluation (DUE) and State of the Art (SoTA), performing searches on clinical trial databases and Adverse Event (AE) databases, authoring SoTA documents, and creating high-level summaries of literature, clinical, and non-clinical test reports.
At Celegence, she leads a team of medical writers who specialize in creating various regulatory documents such as CEPs, CERs, PMS Plans, Post-Market Surveillance Reports, Periodic Safety Update Reports, and Post-Market Clinical Follow-up Plans and Reports.

Dr. Anushree Singh
Associate Manager, Medical Device Services
Celegence

Dr. Anushree Singh has a Doctorate degree in Neuro-oncology and Master’s degree in Bioscience (Human Genetics), and an overall experience of 6 years working as a researcher and lecturer, and 4.5 years in the medical devices industry.
She has authored and reviewed EU MDR compliant regulatory documents for medical devices covering a wide range of therapeutic areas – all specialties of dentistry, radiosurgery, diagnostic imaging, neuro-oncology, hemodialysis, female reproductive health, and pneumothorax pulmonology.
At Celegence, she provides strategic advice to customers on regulatory strategy for clinical evaluation, Post-Market Surveillance (PMS) including Post-Market Clinical Follow-up (PMCF), and Clinical Evidence pathways. She leads a team of qualified medical writers, expert in clinical evaluation of simple-to-complex medical devices, authoring various regulatory documents such as Clinical Evaluation Plans and Reports, PMS Plans and Reports, Summary of Safety and Clinical Performance, and PMCF Plans. Her team has successfully completed several projects related to addressing Notified Body observations (BSI, DEKRA, SGS, Eurofins Expert Services Oy) on the road to CE Marking of medical devices under EU MDR.

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