Medical Devices News & Regulatory Info

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 Process

Shilpam 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 Laboratories

Celegence2024-09-18T14:17:28+00:00August 29th, 2024|

Mastering PMCF and PMPF for Regulatory Compliance

Mastering PMCF and PMPF for Regulatory Compliance

Celegence2024-09-18T14:20:43+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 Safety

Celegence2024-08-01T07:02:31+00:00July 31st, 2024|

Conformity Assessment Guide: EU MDR and IVDR Compliance Strategies

Conformity Assessment Guide: EU MDR and IVDR Compliance Strategies

Shilpam Rajput2024-07-30T06:54:11+00:00July 26th, 2024|

Mastering Compliance: Essential Insights into PMS Documentation

Mastering Compliance: Essential Insights into PMS Documentation

Shilpam Rajput2024-06-12T10:41:59+00:00June 12th, 2024|

US FDA Medical Device Classification and Determination

US FDA Medical Device Classification and Determination

Celegence2024-05-16T15:07:53+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 Webinar

Shilpam Rajput2024-04-22T17:18:59+00:00April 19th, 2024|

AI-Powered Solutions for Regulatory Compliance in the Medical Device Industry

AI-Powered Solutions for Regulatory Compliance in the Medical Device Industry

Celegence2024-04-11T11:07:45+00:00April 5th, 2024|

Streamline Your MDR & IVDR Document Creation with CAPTIS™

Streamline Your MDR & IVDR Document Creation with CAPTIS™

Celegence2024-04-25T12:06:15+00:00March 26th, 2024|

Medical Device Blog

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 Process

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 Laboratories

Mastering PMCF and PMPF for Regulatory Compliance

Mastering PMCF and PMPF for Regulatory Compliance

Harmonizing ISO 14971:2019 and FDA QMSR for Medical Device Safety

Harmonizing ISO 14971:2019 and FDA QMSR for Medical Device Safety

Conformity Assessment Guide: EU MDR and IVDR Compliance Strategies

Conformity Assessment Guide: EU MDR and IVDR Compliance Strategies

Mastering Compliance: Essential Insights into PMS Documentation

Mastering Compliance: Essential Insights into PMS Documentation

US FDA Medical Device Classification and Determination

US FDA Medical Device Classification and Determination

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 Webinar

AI-Powered Solutions for Regulatory Compliance in the Medical Device Industry

AI-Powered Solutions for Regulatory Compliance in the Medical Device Industry

Streamline Your MDR & IVDR Document Creation with CAPTIS™

Streamline Your MDR & IVDR Document Creation with CAPTIS™

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