Medical Devices News & Regulatory Info

How AI Speeds Up Systematic Literature Reviews by 60%

How AI Speeds Up Systematic Literature Reviews by 60%

Shilpam Rajput2025-02-04T05:54:14+00:00February 4th, 2025|

Mastering Benefit-Risk Analysis for EU MDR Compliance

Mastering Benefit-Risk Analysis for EU MDR Compliance

Shilpam Rajput2025-02-13T13:31:47+00:00January 24th, 2025|

Medical Writers’ Experience: AI and Automation Transform Regulatory Workflows – Q&A

Medical Writers’ Experience: AI and Automation Transform Regulatory Workflows – Q&A

Shilpam Rajput2024-12-06T11:45:58+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 2024

Shilpam 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 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

Celegence2025-02-13T13:33:14+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|

Medical Device Blog

How AI Speeds Up Systematic Literature Reviews by 60%

How AI Speeds Up Systematic Literature Reviews by 60%

Mastering Benefit-Risk Analysis for EU MDR Compliance

Mastering Benefit-Risk Analysis for EU MDR Compliance

Medical Writers’ Experience: AI and Automation Transform Regulatory Workflows – Q&A

Medical Writers’ Experience: AI and Automation Transform Regulatory Workflows – Q&A

Shape the Future of Medical Technology Regulation – MTI Survey Insights 2024

Shape the Future of Medical Technology Regulation – MTI Survey Insights 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 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

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