Digitalizing a Quality Management System
Rolling Out the MasterControl eQMS
A global leader specializes in designing medical devices for orthopedic use with a headcount of over 400 staff users expanding operations in domestic and global markets. In order to develop on the international stage and bring their products to market quickly, companies operating in the medical devices sector need to keep up with changing regulations. With the aim of turning red tape into a blue ribbon, client went digital with its QMS.
The company’s decision has been rewarded with better quality management and smoother compliance with key aspect of Quality, Regulations, and Market Access
Regulatory Strategy: Conforming with regulations and standards, including MDR, ISO 13485:2016, and FDA CFR 21 Part 820. Being awarded international certifications such as MDSAP
Development: Supporting Amplitude with its organic growth and development in the international market.
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Great content! Super high-quality! Keep it up! 🙂