Case Studieselena2021-02-17T09:48:31+00:00

Case Studies

Learn how Celegence has successfully supported global medical device organizations in navigating critical regulatory challenges and more.

Shilpam Rajput2024-04-24T18:19:58+00:00

CEP, CER and PSUR Consulting for a Global Medical Device Manufacturer

CEP, CER and PSUR Consulting for a Global Medical Device Manufacturer

Shilpam Rajput2024-04-24T15:19:55+00:00

Clinical Evaluation and Support with Notified Body Observations for an Emergency-Use Medical Device

Clinical Evaluation and Support with Notified Body Observations for an Emergency-Use Medical Device

Celegence2024-04-24T15:21:52+00:00

PMS Support Including Execution and Documentation of PMCF Surveys for a Global Medical Device Manufacturer

PMS Support Including Execution and Documentation of PMCF Surveys for a Global Medical Device Manufacturer

Celegence2024-04-24T15:20:15+00:00

End-to-End Documentation Support for In Vitro Diagnostic Regulation (IVDR)

End-to-End Documentation Support for In Vitro Diagnostic Regulation (IVDR)

Celegence2024-03-18T10:26:36+00:00

In Vitro Diagnostic Regulation (IVDR) Gap Assessment & QMS Support for Class D Devices

In Vitro Diagnostic Regulation (IVDR) Gap Assessment & QMS Support for Class D Devices

Celegence2024-04-24T15:23:27+00:00

In Vitro Diagnostic Regulation (IVDR) Consulting for a Class A Device with Software

In Vitro Diagnostic Regulation (IVDR) Consulting for a Class A Device with Software

Celegence2024-04-30T05:20:34+00:00

USFDA De Novo Regulatory Submission for Software as a Medical Device (SaMD) Products

USFDA De Novo Regulatory Submission for Software as a Medical Device (SaMD) Products

Celegence2023-11-14T11:29:05+00:00

Regulatory Intelligence Consulting Support for an EU Medical Device Manufacturer - Feature

Regulatory Intelligence Consulting Support for an EU Medical Device Manufacturer

Regulatory Intelligence Consulting Support for an EU Medical Device Manufacturer

Celegence2023-10-31T14:58:56+00:00

Technical Document Remediation Sterile Accesories - Feature

Clinical, Risk and Technical Document Remediation for Sterile Accessories and Adapters

Clinical, Risk and Technical Document Remediation for Sterile Accessories and Adapters

Celegence2023-10-23T17:44:34+00:00

Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership - Acumed - Case Study - Feature

Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership – Acumed

Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership – Acumed

Celegence2023-07-24T11:18:54+00:00

Regulatory Consultation Documentation Blood Flow Measurement EU MDR Services - Feature

Regulatory Consultation & Documentation for Blood Flow Measurement Meters

Regulatory Consultation & Documentation for Blood Flow Measurement Meters

Celegence Admin2023-04-28T11:24:45+00:00

MDR CER Cardiac Software - CAPTIS - Case Study

CAPTIS™: MDD to MDR CER Remediation of a Standalone Software

CAPTIS™: MDD to MDR CER Remediation of a Standalone Software

Celegence2023-03-21T16:43:29+00:00

CER Writing Support - Medical Device Software Scleroris - Case Study - Feature

CER Writing Support: Clinical Evaluation of Clinical Decision Support Software

CER Writing Support: Clinical Evaluation of Clinical Decision Support Software