Implementing and Maintaining PMS & Performance Evaluation under the IVDR – Webinar Replay James Shearn is Celegence’s Regulatory Affairs Subject Matter Expert for Medical Devices and IVDs. He has worked in the Medical Devices and In Vitro Diagnostic Devices (IVD) sector for 27 years. Webinar Background: The EU In Vitro Diagnostic Devices Regulation
Implications for Medtech Companies with FDA Rollout of the New QMSR to Replace Current QSR - Webinar What: Webinar - "Implications for Medtech Companies with FDA Rollout of the New QMSR to Replace Current QSR" When: Tuesday, November 15th, 2022, at 10 am CT Where: Online Event How: Register Here Why: This webinar will
Implementing and Maintaining PMS and Performance Evaluation under the IVDR - Webinar What: Webinar - “Implementing and Maintaining PMS and Performance Evaluation under the IVDR” When: Thursday, September 29th, 2022, at 10 am CT Where: Online Event How: Register Here Why: This webinar will illustrate how the PMS process interoperates with other systems including
Unveiling Impactful Methods to Strengthen Device Claims - Webinar What: Webinar - “Unveiling Impactful Methods to Strengthen Device Claims” When: Tuesday, July 19th 2022 at 10 am CT Where: Online Event How: Register Here Why: Join us to examine the best practices to determine measurable claims, identifying clinical endpoints or surrogate endpoints, to
Cost-Effective CER Writing and Maintenance - Webinar What: Webinar - Productivity Improvements for Cost-Effective CER Writing and Maintenance When: Wednesday, March 30th at 9 am (EST) Where: Online Event How to Register: Productivity Improvements for Cost-Effective CER Writing and Maintenance Why: Join this webinar to get a first-hand look at this ground-breaking functionality
In Vitro Diagnostic Regulation (IVDR) Rollout for Legacy & New Devices - Webinar What: Webinar - Navigating the In Vitro Diagnostic Regulation (IVDR) Rollout for Legacy & New Devices When: Tuesday, February 22nd at 10 am (EST) Where: Online Event How to Register: Navigating the In Vitro Diagnostic Regulation (IVDR) Why: Join
Ensuring Compliance for your IVD's Performance Evaluation - Webinar What: Webinar - Ensuring Compliance for your IVD's Performance Evaluation When: Tuesday, November 16th at 10 am (EST) Where: Online Event How to Register: Ensuring Compliance For Your IVD's Performance Evaluation Why: Join us to examine the essential components of a PER and how
Technology Innovation in EU MDR Compliance Shruti Sharma has 5 years of experience in Medical writing, specializing in Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance (SSCP) Reports, and Post-Market-Surveillance Reports (PMSRs). She has been the lead author for Clinical Evaluation Plans and Reports (CEP/CER) for device
The Ins and Outs of Post Market Surveillance Under the EU MDR - Webinar What: Webinar - The Ins and Outs of Post Market Surveillance Under the EU MDR When: Tuesday, July 13th at 10 am (EST) Where: Online Event How: Register online now. Why: Join us to examine the Post Market Surveillance
Medical Device Virtual Summit - Afternoon Program To review the agenda of the morning sessions, explore here! What: Medical Device Virtual Summit When: May 25th from 9:00 am - 3:00 pm EST Where: Online Event How: Register online now Why: Make sure you join us for a day of industry insights into
