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Chris Vasquez replied to the topic AMDD in the forum Clinical Trials for Medical Devices 7 years, 11 months ago
As someone who is starting there career within the medical device industry and applying what was learned in class, I felt that applying my knowledge from class concurrently with the application aspect helps me to fully understand what goes on within this type of industry. I personally work within the validation aspect, and it was great having the listen on validation, while writing my protocols and executing them, I gained the fundamental base of my industry knowledge from this class and medical device development, which helped my transition from my previous role within a lab to an engineering role. Ideally, I would’ve like it if we had covered the whole aspect of learning how to write different types of protocols or learn how to approach them accordingly. I know that each company has a set standard of writing different types of protocols/validations, but it would’ve been nice to apply this scenario within a simulation. Like given a simulation to validate a piece of equipment, what would be the steps to do that and write a protcol for each phase of validation.
Chris