Regulatory compliance in the medical device industry is serious business. At stake are patient safety, doctor and company reputations, and the potential for large fines and negative publicity if something goes wrong due to perceived negligence.
Deploying a Quality System demands a solid, joint solution that features seamless integration with an Enterprise Resource Planning (ERP) system. Blended effectively, separate components can join together to create a far more powerful quality program. By drawing on their complementary strengths, a two pronged compliance strategy and tool package gives medical device companies the assurance that they have a state of the art Quality System that meets or exceeds regulatory expectations and improved operational efficiency.
Perhaps most importantly, a combined top shelf partnership will deliver a flexible solution that can grow and adapt to changing regulatory and business demands. New regulations and company growth can be addressed with relative ease when a medical device company employs a robust Quality System.