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Saudi Food & Drug Authority (SFDA) compliance support for Laboratory Management Software Manufacturer​

Saudi Food & Drug Authority (SFDA) compliance support for Laboratory Management Software Manufacturer​

Project Summary

Medical writing and consulting services for creation of Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) in compliance with MDS-REQ-001, as required by the Saudi Food & Drug Authority (SFDA), for a Class A Software as a Medical Device (SaMD) classified under MDS-G008.​

Celegence uses their proprietary CAPTIS® Platform to search for literature, write, review, and maintain the documents.

Highlights:

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Draft CEP and CER for a Class A medical device in accordance with SFDA guidelines

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Maintain high-quality standards through multi-level internal reviews and QA processes

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Created State-of-the Art to evaluate current technologies and establish safety and performance benchmarks from similar devices

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Alignment of information across all documents

Project Achievements

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Enhance regulatory compliance through expert strategic guidance from Celegence

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Created standardized CEP/CER template to ensure consistency, and SFDA-compliance

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Continuous improvement and feedback loops for quality improvement and operational efficiency

Project Success

Key to success of this partnership is Celegence’s experienced regulatory experts working closely with the client to deliver multiple SFDA-compliant documents within tight timelines and getting approval within timeframe aligning to clients marketing strategy. ​.

Need SFDA-Compliant Documentation for Your SaMD?

Celegence delivers high-quality CEPs and CERs in line with SFDA requirements, supported by CAPTIS® and expert regulatory guidance—ensuring timely approvals. Email us at info@celegence.com to discuss your SFDA compliance needs.

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From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.

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