Navigating the MDR/IVDR Conformity Assessment Maze: Pitfalls and Pathways

What: Webinar “Navigating the MDR/IVDR Conformity Assessment Maze: Pitfalls and Pathways”
When: Tuesday, May 28, 2024 | 10:00 AM ET
Where: Online Event
How: Register Here

This webinar will provide a comprehensive overview of the conformity assessment routes under the In Vitro Diagnostic Regulation (IVDR) and Medical Devices Regulation (MDR). We will explore the different pathways to compliance, highlighting common pitfalls and offering strategies/best practices to navigate them successfully. Our Subject Matter Expert presenters will also share insights and practical tips to help you achieve and maintain compliance with the latest EU regulations.

This featured presentation will be led by Celegence’s Joseph Richardson Larbi and Smridula Hariharan. 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.

Celegence will be hosting the Webinar on Tuesday, May 28, 2024, 10:00 am ET. Register online now!

Joseph Richardson Larbi, MSc. RA

Director of Medical Device Regulatory Affairs

• Joseph has a master’s degree in medical device regulatory affairs and over 2 decades of experience in medical device life cycle management as well as quality management systems (certified to ISO 13485, ISO 9001 & ISO/IEC17025).
• His key expertise includes the preparation and maintenance of technical files, product safety and vigilance reporting, clinical evaluations, risk assessment, regulatory audits, CE marking, and notified body opinion submissions.
• Medical device industry – Joseph has experience in diabetes management devices, nicotine replacement therapy (NRT) devices, pressurized metered dose inhalers (pMDI), ophthalmic devices, and ECMO therapy devices.
• Joseph has worked for small, medium, and large Biotech companies such as Roche, OBG Pharmaceuticals, and Kind consumer Ltd.

Smridula Hariharan
Senior Manager – Medical Device Services

• Smridula Hariharan has a master’s degree in quality assurance (pharmacy), and over 12 years of experience in Medical Writing for Medical Devices/invitro diagnostics 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).

• Understand the key requirements and options available for a conformity assessment
• Identify common pitfalls and challenges in the conformity assessment process under the MDR/IVDR
• Learn strategies to effectively navigate the conformity assessment process and ensure compliance with the MDR/IVDR
• How to plan effectively for a conformity assessment
• Key learnings and best practices during a conformity assessment
• Understand how to effectively engage with notified bodies from application/contract signing to certificate recommendation

This webinar is aimed at Medical Device Professionals of all levels working 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

“Navigating the MDR/IVDR Conformity Assessment Maze: Pitfalls and Pathways” webinar will be held on Tuesday, May 28, 2024, 10:00 am ET. Make sure you secure your place at the webinar by registering now.

As a leading global regulatory solutions and services provider led by Sonia Veluchamy, Celegence is dedicated to supporting your organization in achieving maximum compliance with EU MDR and EU IVDR. 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.

For more information on how we 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 medical device services.