Case Study: MDR Gap Analysis – Specimen Management System: Reproductive Medicine

Background – Client Needs:

This system provides laboratories with a secure system that enables the effective management of high volume of cryogenically preserved specimens. which is intended to provide specimen inventory and environmental management at low temperatures. The system’s central operating system provides end-users with clinic management, specimen management, specimen identification, digital chain of custody, storage workflows and storage environment information to allow them to reliably manage cryopreserved fertility issues.

The system integrated with software is used in assisted reproductions clinics to manage patient specimens. Clinic personnel can use this software system to store, retrieve, and record information about patients and specimens. The project was initiated to author clinical evaluation report.

Project Initiation & Key Objectives:

The manufacturer approached Celegence to author clinical evaluation plan and report for their next generation storage device. Further the project extended to Submission Plan, which includes regulatory submission requirements for the applicable markets – United States, Europe, Japan, Mexico, Australia, and Rest Of World (ROW)

Celegence Solution & Approach:

Celegence performed MDR gap assessments for S/W life cycle processes in compliance to IEC 62304; authored CER in compliance to MDD and is approved for CE Mark; and provided regulatory consultation for launching products in the US, Europe, Mexico, Australia, and Japan.

Project Achievements

The clinical evaluation created by Celegence had fewer notified body review comments and was updated within a short span. The solution approach provided on regulatory pathway was highly appreciated.

Project Outcomes

The project was delivered on time and the project was further expanded to perform Gap assessments for IEC 62304, and Creation of usability report.

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