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Program Management
End-to-End Project Management
We offer a systematic project management approach to oversee the entire medical device development cycle, accelerating product registration and market entry.
Excellent Project Management
A Trusted Partner

As project management experts in the medical device industry, we provide global clients with end-to-end, high-standard, and efficient project implementation services. 

By leveraging the indepth integration of  the ISO 13485 quality management system and agile project management methodologies ,we have established a comprehensive project lifecycle control mechanism—from requirements analysis and solution design to production and delivery. 

Our professional team is not only well-versed in regulatory requirements for medical devices but also excels at risk anticipation and resource optimization, helping clients mitigate potential risks  and shorten product time-to-market. We understand the unique nature of medical device projects:

Compliance Requirements
Establish project management processes that fully compliant with FDA, CE, and other regulatory standards.
Multidisciplinary Collaboration
Efficiently coordinate resources across R&D, manufacturing, quality assurance, and other departments.
Schedule Control
Utilize critical path management to ensure on-time achievement of project milestones.
Risk Management
Implement risk management practices to proactively identify and resolve potential problems proactively.
Project management experience
Managed over 1,000 medical device projects
Expertise spanning drug delivery, in vitro diagnostics, cardiovascular, surgical, and other key therapeutic areas
A project management team with 10+ years of experience in the medical device sector
A proven track record of on-time project delivery