A leading Malaysia-based developer of thin nitrile glove technology and manufacturer of premium gloves approached Freyr for medical writing services. The client was planning to CE-certify their glove products as per the EU MDR and required the revision of Clinical Evaluation Report (CER) for EU MDR compliance. In addition, they wanted services to compile the Periodic Safety Update Report (PSUR). Though the client did not have the required data to update the CER and compile the PSUR, Freyr ensured to perform a detailed review of the CER and extensive data mining for compiling the PSUR as per the Health Authority requirements.
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