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Are You Ready for IEC 62304? Software Development Takes On New Role in Medical Manufacturing

Andy LaFrazia

The recent IEC 62304 standard has gotten a lot of hype lately, as manufacturers throughout the medical industry grapple with what is quickly becoming the industry go-to for medical device software development. The FDA has adhered to the standard since 2008, and it has become normative for CE marking in recent years as well.

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Medical Manufacturing is a Team Effort at ControlTek

ControlTek medical manufacturing

Medical manufacturing is one of the fastest-growing manufacturing industries, but it’s certainly not without unique challenges.

At ControlTek, our entire design engineering, project management and contract manufacturing teams are all highly experienced with the often complex requirements as identified by the FDA.

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