A Clear Vision: Developing the Right Strategy to assure Compliant Labeling Inspection

The continual tightening of regulation around the packaging and labeling of medical devices has so far failed to stimulate a transformation of labeling infrastructure and approach among global device manufacturers.

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Delaying Tactics – How a Postponement Strategy can transform Documentation Processes and bring Supply Chain Agility

The introduction of Unique Device Identification (UDI)regulations signals a seismic shift in theMaintaining an efficient supply chain is widely acknowledged as a key strategic imperative for businesses across the global life science sectors.

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Ensuring FDA Compliance: The Essential Guide to FDA 21 CFR Part 11

FDA 21 CFR Part 11 allows Medical Device and Life Science organizations to use electronic records and signatures in place of paper. This helps organizations reduce the cost of managing and documenting their entire labeling lifecycle, from routing and approval workflow, version control and comparison, to audit trails and reports.

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