The New Guideline That Affects All Medical Device Companies Are Not Compliant

1574 WordsJan 11, 20167 Pages
Background The FDA has established a new guideline that affects all medical device companies operating in FDA regulated environments. The new guideline requires that all medical device companies be compliant with UDI (Unique Device Identifier) requirements within the next one to three years, depending on the device class. Most medical device companies are not compliant and will require a compliant solution to maintain their FDA certification. Description of the Product PRISYM ID offers a turnkey global label management solution (PRISYM 360) that is FDA compliant and meets the UDI requirements and standards. This is unlike any other product offered by PRISYM ID therefore an entirely new course of instruction is being developed.…show more content…
Intended Audience The audience for this instructional unit is medical device professionals consisting of Label Designers, Quality Control, and Production Print Shop technicians. All are computer literate and well versed in the latest Microsoft operating system and a variety of internet browsers. All have been trained and certified by their in house compliance training staff on what the requirements are for the new FDA regulation for unique device identification. The Label Designers tend to be more technically proficient based on their daily use of other applications used for the creation of labels. The label designers are typically the largest group, followed by Printing then Quality Control. The instructional unit concentrates more on the label design process with stand-alone modules for the approval process (Quality Control) and Production Print Shop technicians. A role-based approach is being developed in which a learner who is not doing label design will not need to participate in the entire course of instruction. They need only participate on the initial application overview, followed by the module applicable to their job role. Type and Purpose of Evaluation Since this is a new application release and a corresponding new course of instruction, this will be a formative
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