ERP Software & FDA Compliance, Part 1: Managing Your DMR, DHR, and Product Documentation

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The development of a medical device can take years. Over the course of this time, product information amasses and evolves. From quality documentation and design data to computer-aided design (CAD) files and part specs, the device master record (DMR) and design history file (DHF) are critical but volatile entities in the medical device life cycle. The proper maintenance of these files is essential to not only FDA compliance but also operational success.

Continue reading the blog to learn three ways an ERP system helps overcome common challenges in product doucumentation management.

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