Newsletter | May 7, 2022

05.07.22 -- April's Most Popular Articles & Solutions

Featured Editorial
Top Industry Insights
Most Common Reasons For FDA Form 483 Observations And Warning Letters In Medical Device Environments

When the FDA conducts regulatory inspections, issues that are considered objectionable conditions or compliance violations by FDA inspectors are itemized in a Form 483 or a warning letter. In this article, we help you understand the FDA’s updated approach to medical device regulation and provide information about inspection observations so that it is easier to identify and mitigate compliance issues.

Manufacturing Transfer Requires Cross-Functional Leadership, Resources, And Open Communication

When a manufacturing consolidation strategy emerged for a top-30 medical device original equipment manufacturer (OEM), they found themselves presented with the challenge of needing to close a legacy facility. Rather than transferring the critical manufacturing operations of a Class III industry-leading implantable device to another location, the OEM decided to explore their outsourcing options.

Sustainable Manufacturing: A Guide To Transformation

In this e-book we answer how sustainability transforms manufacturing production and how manufacturers can repurpose old facilities, build green products, and become sustainable.

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