Clinical Evaluation of Dental Medical Devices – Lessons Learned from Notified Body Assessments – Webinar

What: Webinar and Panel Discussion – “Clinical Evaluation of Dental Medical Devices – Lessons Learned from Notified Body Assessments”
When: Tuesday, February 28th, 2023, at 10 AM ET
Where: Online Event
How: Register Here
Why: Join us to examine the best practices to conduct clinical evaluations of dental medical devices and addressing observations from Notified Bodies, and successfully meeting regulatory requirements.

The assessment of Clinical Evaluation Plans and Reports submitted to Notified Bodies since the implementation of EU MDR has provided insights into deficiencies and challenges in meeting the requirements of Article 61 of the EU MDR. This has especially impacted the dental device industry in maintaining regulatory compliance for their products and ensuring access to the EU market. The team of clinical and regulatory experts at Celegence has supported several leading dental device manufacturers in conducting clinical evaluations for their devices and addressing observations from Notified Body reviewers, and successfully meeting regulatory requirements.

• Common gaps in Clinical Evaluation Plans and Reports identified by Notified Bodies
• Clinical evidence requirements to support the safety and performance of dental devices
• Defining clinical benefits and measurable safety and performance objectives
• Determination of acceptance criteria for safety and performance from the state-of-the-art
• Analysis of risks identified from the clinical evaluation and alignment with the Risk Management documentation
• Post-Market Clinical Follow-Up (PMCF) as an outcome of clinical evaluation

Our expert panelists will discuss practical examples and case studies from Notified Body assessments of Clinical Evaluation Plans and Reports of dental devices prepared for compliance with EU MDR. Our lineup of accomplished panelists will also be for a live Q&A session after the presentation.

Celegence will be hosting the WEBINAR on Tuesday, February 28^th at 10 AM ET. Register online now!

Pratibha Mishra​
Manager/Sr. SME, Medical Device Services, Celegence​

• Pratibha Mishra has a master’s degree in Oral Medicine and Maxillofacial Radiology and previously worked as a clinician and lecturer.​
• She has written and reviewed templates and regulatory documentation for medical devices covering a wide range of therapeutic areas – dentistry including implantology, ophthalmology, cosmetic surgery, diagnostic imaging, interventional radiology, gastroenterology, female reproductive health, nephrology, and dialysis, general and electrosurgery, thoraco-pulmonology, cardiology, diabetes, wound care, musculoskeletal disorders, instrument reprocessing and care.​
• At Celegence, she provides strategic advice to customers on regulatory strategy for clinical evaluation, Post-Market Surveillance including Post-Market Clinical Follow-up, and Clinical Evidence pathways. She leads a team of qualified medical writers, expert in clinical evaluation of simple-to-complex medical devices, including Medical Device Software. Her team has successfully completed several projects related to addressing Notified Body observations (BSI, TÜV SÜD, Intertek, GMED, and DEKRA) on the road to CE Marking of medical devices under EU MDR.

Alpa Ben​
Subject Matter Expert (SME), Medical Device Services, Celegence​

• ​Dr. Alpa Ben has a bachelor’s degree in Dental Surgery and experience as a clinician.​
• She has been associated with the healthcare service industry for over 12 years and has experience in multiple domains such as Pharmacovigilance, Labeling, Risk Management, Complaints Handling, and Medical Writing.​
• She has authored and reviewed EU MDR compliant regulatory documents such as Clinical Evaluation Plans and Reports, Post-Market Surveillance Reports, and Summary of Safety and Clinical Performance for medical devices covering a wide range of therapeutic areas – dentistry, cardiology, gastroenterology, endoscopy and dialysis, and diagnostic and interventional radiology.​
• At Celegence, she works as an SME and a clinical reviewer for regulatory documentation related to simple-to-complex medical devices including Medical Device Software.​

Anushree Singh​
Team Lead, Medical Device Services, Celegence​

• 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.​
• 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, and hemodialysis.​
• At Celegence, she has led projects related to EU MDR compliance for customers that are leading manufacturers of dental equipment, dental consumables, and maxillofacial imaging devices. Her team specializes in authoring various regulatory documents such as Clinical Evaluation Plans and Reports, Post-Market Surveillance Plans and Reports, and Summary of Safety and Clinical Performance.

• Hear the key insights and best regulatory approach into the best practices to clinical evaluation of dental medical devices
• Examine examples and relevant case studies from Notified Body assessments of Clinical Evaluation Plans and Reports of dental devices
• Have your most pressing questions answered during the Q/A session

This webinar is designed for persons responsible for the technical documentation of dental medical devices, including:

• Quality assurance managers
• Manufacturers of dental medical devices
• Top management
• R&D managers
• Persons responsible for technical files
• Regulatory Affairs professionals
• Clinical managers

“Clinical Evaluation of Dental Medical Devices – Lessons Learned from Notified Body Assessments” Webinar will be held on February 28th, 2023, from 10:00 am – 11 am ET. Make sure you secure your place at the webinar by registering now.

Celegence provides the medical device industry with consulting services and technology solutions that are tailored to the evolving needs of manufacturers. Our suite of services including EU MDR and IVDR related support allows you to focus on your core responsibilities. With our guidance, bringing your devices to the market and keeping them there will be easier for your regulatory and quality teams.

Get in touch today to discuss your regulatory needs by reaching out to info@celegence.com or contact us online. Find out more information on Celegence’s CER/CEP Writing Services here.