Webinar - Clinical Evaluation of Dental Medical Devices - Lessons Learned from NB Assessments скачать в хорошем качестве

Webinar - Clinical Evaluation of Dental Medical Devices - Lessons Learned from NB Assessments

Celegence (https://www.celegence.com/services/me...) provides the medical device industry with consulting services that are tailored to the evolving needs of manufacturers. Our suite of services including EU MDR 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. Webinar Background 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. Webinar and Panel Discussion Focus 1. Common gaps in Clinical Evaluation Plans and Reports identified by Notified Bodies 2. Clinical evidence requirements to support the safety and performance of dental devices 3. Defining clinical benefits and measurable safety and performance objectives 4. Determination of acceptance criteria for safety and performance from the state-of-the-art 5. Analysis of risks identified from the clinical evaluation and alignment with the Risk Management documentation 6. Post-Market Clinical Follow-Up (PMCF) as an outcome of clinical evaluation Our medical device expertise also includes region specific support for submissions, and global regulatory consulting and intelligence. If your team has not begun addressing any of these areas above, reach out today for a Celegence MDR Gap Analysis that will comprehensively examine all relevant aspects of your regulatory process. Reach out to us at [email protected]!