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Simply being FDA compliant — even if you’re following every regulation as closely as it can be followed — may not be enough to make your medical device one of high quality, and it is high quality devices that will not result in recalls or adverse events. Read More
Epimed International Inc. was cited in a Form 483 for inadequate procedures for handling of complaints, design validation, design transfer, control over products, services and suppliers, and accepting incoming products at its Johnstown, N.Y. facility. Read More
Combining various risk metrics into a single number can help manufacturers rank suppliers according to risk and identify those that might need to be dropped. Read More
The International Organization for Standardization has released a standard that specifies design and performance requirements of small-bore Luer connectors used in intravascular applications or hypodermic connections in medical devices and accessories. Read More
A high-precision compounding and dispensing device used to mix two solutions together received a warning letter following an inspection that revealed a failure to maintain procedures for validating the device design. Read More
Certain Class II device manufacturers will get two more years to comply with the FDA’s unique device identifier rule that was scheduled to become effective Sept. 24. Read More
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