FDA Inspections

If your company holds a 510(k) on a device, the FDA may perform an inspection of your facility for any number of reasons including routinely scheduled investigations or response to a reported problem.  These inspections are supposed to happen at least once every two years.  There is no requirement, though, for the FDA to give…

Device History Record

The FDA requires manufacturers to maintain Device History Records (DHR).  Within ISO 13485, there isn’t a specific requirement for a DHR, but it does require the manufacturer to create all of the individual records the FDA requires the DHR to contain.  The Device History Record is meant to be a collection of records containing all…

Case Study – USDA Regulated Freezers

Mesa Global Services recently completed an Installation and Operational Qualification (IOQ) on two large freezers that are used for the storage of USDA regulated products.  The System Information and the electrical utility supply information for the freezers verified and documented prior to the temperature mapping of the freezers. 30 DataTrace MPRF data loggers were utilized…

What is Validation?

There are three commonly used types of validation protocols for systems and equipment: Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) IQ protocols should be designed to: Record critical information applicable to the equipment, including equipment attributes such as the manufacturer, serial number, model number, equipment tag or asset number, materials of construction, and…

Differentiating Design Validation & Design Verification

Design Validation frequently gets confused with Design Verification – they are quite different processes, though.  With verification, you’re making sure that the product meets the requirements identified by customers and regulations.  Validation is where you actually build a functioning version of the product to make sure it performs as expected. In Section 820.3(z), the FDA…