Mastering Compliance: Essential Insights into PMS Documentation – Webinar

• What: Webinar in partnership with Medtech Intelligence – “Mastering Compliance: Essential Insights into PMS Documentation”
• When: Wednesday, April 24th, 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 where we delve into the essential aspects of PMS documentation. Discover key insights and effective strategies to navigate the complexities of PMS documentation and empower yourself with knowledge to ensure compliance and efficiency. Don’t miss this opportunity to enhance your understanding and expertise in this critical area. Register now to secure your spot!

Join us for an insightful webinar as we explore the crucial role of PMS documentation in the realm of medical devices. Gain invaluable insights into ensuring compliance with regulatory requirements and learn best practices to enhance your organization’s PMS documentation processes. Whether you’re a regulatory affairs specialist, quality assurance professional, or involved in product development, this webinar is tailored to equip you with the necessary knowledge to stay ahead in the ever-evolving landscape of medical device compliance. Don’t miss out on this opportunity to elevate your understanding and skills.

This featured presentation will be led by Celegence’s Dr. Anushree Singh, Associate Manager, Medical Device Services and Kasturi Rao, 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, April 24, 2024, 10:00 am ET. Register online now!

1. Dr. Anushree Singh, Associate Manager, Medical Device Services

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 reports, 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.

2. Kasturi Rao, Team Lead, Medical Device Services

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.

• 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.

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

As a leading global regulatory solutions and services provider, Celegence is dedicated to supporting your organization in achieving maximum compliance with EU MDR regulations. Our comprehensive and technology-enabled services include EU MDR Gap Analysis, PMS Reporting, Clinical Documentation, and Notified Body Interactions, designed to streamline your processes, save time, and enhance operational efficiency.

Now is the ideal time to embrace innovative technologies such as CAPTIS™, our groundbreaking EU MDR & IVDR solution. CAPTIS empowers medical writers by increasing efficiency, ensuring ongoing compliance, and facilitating seamless adaptation to regulatory requirements. With Celegence and CAPTIS by your side, you can confidently navigate the complexities of EU MDR compliance and drive sustainable success in the medical device industry. Embark on your journey towards regulatory excellence with Celegence today.

“Mastering Compliance: Essential Insights into PMS Documentation” webinar will be held on Wednesday, April 24th 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.