Medical Devices

The Platform for Product Data Management and Syndication  

The osapiens platform provides efficiency, flexibility, ease of use and superb integration capabilities for Medical Device companies of all sizes.  With osapiens for Medical Device you can manage and syndicate Product Master Data (GUDID, EUDAMED, GDSN, etc.) satisfying your regulatory and commercial Product Master Data Management and Syndication needs.  We provide the optimal soultion(s) for companies of all sizes all in a pre-FDA validated environment with USDM Cloud assurance.  

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How osapiens Empowers the Medical Device Industry  

For medical device manufacturers, complete and accurate product data are essential to meet both regulatory and commercial trading partner requirements. Regulations such as EUDAMED (European Commission) and GUDID (US FDA) require the submission of comprehensive product information to their respective databases before products can be marketed. This data forms the foundation of a safe and secure healthcare supply chain, enabling more reliable post-market surveillance and significantly improving patient safety.

The osapiens platform supports regulatory requirements including EUDAMED, GUDID, SFDA (Saudi-DI), TFDA (Taiwan), and the Netherlands LIR (via GDSN), as well as upcoming requirements from TGA Australia, Swissmedic, Emirates Health Services (EHS), and Dubai Health Authority (DHA).

By automating data exchange, osapiens reduces manual effort across the entire product lifecycle, streamlining compliance and improving operational efficiency.

osapiens Optimal Solutions for Companies of all sizes

osapiens for medical devices provides the best hands on training and guidance to all of our clients.  We offer superior Machine to Machine (M2), Document upload and Portla Entry options 

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Reliable regulatory compliance

Meet international requirements such as EUDAMED, GUDID, and LIR. The platform automates data formatting, validation, and submission – ensuring accuracy and audit-readiness.

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Accelerated market access

Streamline the delivery of relevant product data. With structured and validated information, you can bring medical devices to market faster and update them more efficiently.

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