This paper explores how medical device manufacturers are rethinking their product development approach beyond the traditional design controls e.g. Design History File (DHF) - and Design Master Record (DMR) - and are looking for a single unified business platform, which supports the total product development process across the enterprise.
This approach breaks down organizational boundaries so companies can achieve the ultimate goal of delivering innovative medical devices while ensuring upon patient safety: connecting the dots between ideation, design / development, V&V testing, regulatory submissions/approvals, manufacturing, commercialization and post-market follow up, they ensure that quality and regulatory information are shared across the enterprise and become an integral part of the product development process.
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