Enabling compliant global distribution for a leading medical device manufacturer 

Overcoming regulatory challenges in healthcare: Automated compliance and secure data management 

A major medical device manufacturer faced the challenge of managing regulatory compliance for the global distribution of thousands of product variants. The business needed to track and monitor approval status for each product in every country, ensuring only compliant items could be shipped. Legacy systems made it difficult to maintain historic data, manage growing volumes, and adapt to evolving regulatory requirements. The company required a robust, scalable solution to streamline compliance, support business growth, and enable efficient, secure data management across its global operations. 

Centralised regulatory tracking for global compliance and growth 

We partnered with the client to design and implement a regulatory solution that integrates with multiple ERP systems. The solution included: 

• Centralised tracking and management of product approvals for global distribution 

• Secure storage and maintenance of historic data, supporting regulatory audits and new requirements 

• Scalable architecture to accommodate growing data volumes and new product introductions 

• Ongoing enhancements and support for cloud migration, ensuring future readiness 

• Seamless integration with existing business processes and systems 

By collaborating closely we helped the client automate compliance checks, reduce manual intervention, and maintain a single source of truth for regulatory data. 

Compliance, efficiency, and lasting value 

• Efficient, compliant global distribution enabled by real-time regulatory tracking  

• Secure, scalable data management that supports business growth and innovation  

• A trusted long-term partnership that continues to deliver ongoing enhancements and business value