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The Importance of Validation

Validation is the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process and or device can consistently deliver a quality product. Process validation involves a series of activities...

Fulfilling Requests During an Inspection

In this blog article series on regulatory affairs inspections, we talked about the importance of making a good impression when the inspector or investigator arrives and how to do that. To prepare for the inspection – which can happen anytime – we talked about putting...

How to Find the Perfect Consultant

After an hour-long meeting of highly caffeinated conversations, the executive leadership team woke up this morning creating an Excel list of action items that topped off your inbox. The dreams of last night turned into the demands of the workday today. This Excel list...

Effective Risk Management For Medical Devices

Risk Management is your system of management policies, procedures, analysis practices, and monitoring risk.  An effective risk management program is an essential element in the life cycle of a medical device.     A Hazard is a potential source of harm.  A Risk is your...

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