Last seen: Dec 3, 2022
Prior to this lecture I had never learned about the AdvaMed Code of Ethics. For those unfamiliar with the topic, the AdvaMed Code of Ethics outlines g...
A non-disclosure agreement (NDA) is a legally enforceable agreement between individuals or parties that ensures information which will be discussed or...
As per the responses from my peers, all businesses require contracts. As per this weeks lecture, contracts must demonstrate the capacity and intention...
Organizational culture is a system of shared values, norms, and beliefs that are internally and externally promoted. An organization's culture typical...
I believe a successful project team must have a diverse set of skills and experiences in order to complement one another in areas that ones' peers may...
As per the PMBOK Guide, there are eight types of organizational structures seen when running a business: organic, functional, multi-divisional, matrix...
Post-market surveillance is the practice of monitoring medical devices as well as taking reactive and proactive actions once the equipment is sold and...
As someone who works primarily on post-market surveillance of medical imaging equipment, it is my responsibility to determine the root cause when a sy...
I believe only conducting verification and validation studies is acceptable for a class I medical device or a class II medical device that is substant...
It is important to note that design controls are just a singular subpart that are reviewed to ensure compliance with quality system regulations. Desig...
As per the responses from most of my peers, without clear design controls the project timeline will continuously have to be modified and updated as ne...
Upon reading through responses from my peers, this seems like really fun thread to respond to. Another example of a medical device with important desi...
As we discussed, there are nine design controls listed in 21 CFR 820.30 which include planning, input, output, review, verification, validation, trans...