Medical Writers’ Experience: AI and Automation Transform Regulatory Workflows – Q&A Medical Writers’ Experience: AI and Automation Transform Regulatory Workflows – Q&AShilpam Rajput2024-11-28T08:33:38+00:00November 28th, 2024|
Shape the Future of Medical Technology Regulation – MTI Survey Insights 2024 Shape the Future of Medical Technology Regulation – MTI Survey Insights 2024Shilpam Rajput2024-11-20T13:00:15+00:00November 20th, 2024|
Why Clinical Evaluation Reports (CERs) are Challenging and How Celegence Can Streamline the Process Why Clinical Evaluation Reports (CERs) are Challenging and How Celegence Can Streamline the ProcessShilpam Rajput2024-10-10T19:10:35+00:00October 10th, 2024|
New FDA Regulations for Laboratory Developed Tests (LDTs): What It Means to Laboratories New FDA Regulations for Laboratory Developed Tests (LDTs): What It Means to LaboratoriesCelegence2024-09-18T14:17:28+00:00August 29th, 2024|
Mastering PMCF and PMPF for Regulatory Compliance Mastering PMCF and PMPF for Regulatory ComplianceCelegence2024-09-18T14:20:43+00:00August 14th, 2024|
Harmonizing ISO 14971:2019 and FDA QMSR for Medical Device Safety Harmonizing ISO 14971:2019 and FDA QMSR for Medical Device SafetyCelegence2024-08-01T07:02:31+00:00July 31st, 2024|
Conformity Assessment Guide: EU MDR and IVDR Compliance Strategies Conformity Assessment Guide: EU MDR and IVDR Compliance StrategiesShilpam Rajput2024-07-30T06:54:11+00:00July 26th, 2024|
Mastering Compliance: Essential Insights into PMS Documentation Mastering Compliance: Essential Insights into PMS DocumentationShilpam Rajput2024-06-12T10:41:59+00:00June 12th, 2024|
US FDA Medical Device Classification and Determination US FDA Medical Device Classification and DeterminationCelegence2024-05-16T15:07:53+00:00May 16th, 2024|
Strategies for Successful Post-Market Clinical Follow-Up (PMCF) under EU MDR: Insights from a Comprehensive Webinar Strategies for Successful Post-Market Clinical Follow-Up (PMCF) under EU MDR: Insights from a Comprehensive WebinarShilpam Rajput2024-04-22T17:18:59+00:00April 19th, 2024|