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Usability Submission Strategy
Creating a proper usability submission strategy is always valuable when submitting a new medical device for approval in the market.
Will the device be sold over the counter in a supermarket, or prescribed by a physician? Is the device to be sold in the US or the EU? Which risk class does the device belong to? The answers to questions like these will affect the overall design of the usability submission strategy. Therefore, for some clients, formulating the usability submissions strategy can seem like a daunting task.
Deciding what goes into the usability submission strategy involves both usability engineering and regulatory affairs specialists. Fortunately, at Technolution, we have both teams in-house along with specialists in other areas like mechanical engineering and test & verification. This creates an environment, in which nerdy specialists from different backgrounds help each other with the common goal of coming up with the optimal solution for the client.
