Medical device manufacturers and their supply chains must get their products to market quickly while facing new technological challenges, global competition, and the need to mitigate risks. Medical devices with electrical, mechanical, and software components introduce even more obstacles as companies strive to navigate the ever-evolving regulatory landscape including FDA (e.g., FDA 21 CFR Part 11 and Part 820), ISO (e.g., 13485, 14791), UL, OSHA, and environmental compliance (e.g., RoHS, REACH, conflict minerals) initiatives.

So how do medical device manufacturers address regulatory compliance?

Read this white paper to learn the best way to navigate compliance from early concept phases through commercialization with a single system of truth for all product and quality information available to internal teams and partners.

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Thermo Fisher
Bio Rad