Achieving Saudi Arabia Medical Device Marketing Authorization (MDMA) with Precision and Efficiency
CEP, CER and PSUR Consulting for a Global Medical Device Manufacturer
Shilpam Rajput2024-04-24T18:19:58+00:00CEP, CER and PSUR Consulting Support for a Global Medical Device Manufacturer
Clinical Evaluation and Support with Notified Body Observations for an Emergency-Use Medical Device
Shilpam Rajput2024-04-24T15:19:55+00:00Clinical Evaluation and Support with Notified Body Observations for an Emergency-Use
PMS Support Including Execution and Documentation of PMCF Surveys for a Global Medical Device Manufacturer
Celegence2024-04-24T15:21:52+00:00PMS Support including Execution and Documentation of PMCF Surveys for a
End-to-End Documentation Support for In Vitro Diagnostic Regulation (IVDR)
Celegence2024-04-24T15:20:15+00:00End-to-End Documentation Support for In Vitro Diagnostic Regulation (IVDR)
In Vitro Diagnostic Regulation (IVDR) Gap Assessment & QMS Support for Class D Devices
Celegence2024-03-18T10:26:36+00:00In Vitro Diagnostic Regulation (IVDR) Gap Assessment & QMS Support for
In Vitro Diagnostic Regulation (IVDR) Consulting for a Class A Device with Software
Celegence2024-04-24T15:23:27+00:00Project Summary: A manufacturer of
USFDA De Novo Regulatory Submission for Software as a Medical Device (SaMD) Products
Celegence2024-04-30T05:20:34+00:00Case Study: USFDA De Novo Regulatory Submission for Software as a
Regulatory Intelligence Consulting Support for an EU Medical Device Manufacturer
Celegence2023-11-14T11:29:05+00:00Case Study: Regulatory Intelligence Consulting Support for an EU Medical Device Manufacturer
Clinical, Risk and Technical Document Remediation for Sterile Accessories and Adapters
Celegence2023-10-31T14:58:56+00:00Case Study: Clinical, Risk and Technical Document Remediation for Sterile Accessories and Adapters
Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership – Acumed
Celegence2023-10-23T17:44:34+00:00Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership - Acumed Case Study
Regulatory Consultation & Documentation for Blood Flow Measurement Meters
Celegence2023-07-24T11:18:54+00:00Case Study: Regulatory Consultation & Documentation for Blood Flow Measurement Meters Project