Ensuring Regulatory Compliance: The Importance of PPAP in Medical Device Manufacturing 

Ensuring that medical devices are manufactured to precise quality specifications is key for medical device manufacturers. Keeping this thought at the forefront of regulatory compliance issues underscores the importance of constantly fine-tuning manufacturing processes with patient safety in mind. Performance Validation (PV) has successfully worked with a global Medical Device Manufacturer based in Kalamazoo, Michigan […]

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FDA Devices Inspection Summary – FY 2013

A review of the Inspection Observation Summary for FY2013 was conducted with a focus on inspections of Devices. From 10-1-12 to 9-30-13 approximately 1099 device 483’s were issued and a total of 4393 citations were referenced.  This is approximately the same number of 483’s that were issued in 2012 (N=1090), however the number of citations referenced in […]

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