Global Medical Device Company Manages Compliance and Creates a Solid Foundation for Product Master Data Alignment with Oracle PLM Cloud
One can only imagine the lengths that global medical device corporations must go through to ensure that traditional or newly launched medical devices comply with the standards established by a patchwork of international regulatory agencies and clearinghouses. This was the challenge that an Inspirage client faced. A multi-billion-dollar company on the Fortune 500 list for many years, our client had been able to satisfy what was expected. But given its global presence, increased competition, and more red tape created by oversight bodies, the inefficient processes that were enough to get by before were no longer sustainable. The business needed a cloud solution that could systematize and streamline compliance management to avoid the inconsistencies and mismatches leading to communication breakdowns and supply chain slowdowns.
This global medical device company is well-known, highly respected, and has grown considerably as a result. While many advantages derive from sheer size, it also has potential pitfalls. The company operated 10 independent business units, each with its own tasks, assignments, and leadership structures. However, the employees and stakeholders within these units all dealt with medical device regulatory requirements. Among the most comprehensive medical compliance protocols on the books are those from the European Union. The European Union Medical Device Regulation (MDR) contains many different mandates and directives designed to ensure that patient safety is not compromised in the name of innovation.
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