FDA

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…

FDA

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…

Sample Annotated Floor Plan

Keys: Annotated Floor Plans

Vital to the overall success of the project, a complete set of annotated floor plans for monitored appliances and points is important to have for the design, implementation and validation stages of system implementation. Here are examples of how and when floor plans are utilized: System Design – During the design phase of the project,…

FDA

New FDA Food Safety Modernization Act (FSMA) Rules Published

The U.S. Food and Drug Administration (FDA) has made two final Food Safety Modernization Act (FSMA) rules public: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals JDSupra Business Advisor published an article discussing an overview of…

Mesa Monitoring

Keys: Understanding Unique Needs

There is no such thing as “One Size Fits All” when it comes to implementing a Continuous Monitoring (CM) system. Each department within an organization will have its own unique set of needs and requirements. Having each department follow exactly the same set of specifications and/or standard operating procedures will likely not be an optimal…

ViewPoint

Have You Seen the New VP Connect?

With more power, more capacity, and larger expansion capabilities, the new ViewPoint (VP) Connect is the perfect upgrade or facility enhancement. The VP Connect allows existing clients to continue adding on to an existing hardwire system as a direct replacement for the AS-Connect for the AmegaView hardwired system, or offers new clients a powerful solution…