Activity

  • I currently work in the manufacturing department of a medical device company. A lot of the principles from this class tie into what goes on in an everyday basis, but perhaps on a smaller scale. Not everybody is responsible for every part of every project phase. For example the R&D department in my company is in the process of bringing a new device to market. My department will be responsible for ordering extra equipment to accommodate this new product and then validating the process to make it. This includes writing and executing protocols known as Installation/Operation/Performance Qualifications (IQ/OQ/PQ). These are important concepts to understand in medical device industry to validate processes. Besides that, the quality department may be in charge of calibration and determining inspection standards. Also the regulatory department may be in charge of the legal aspects of registering the device with the FDA and other countries. The point is all of the departments work together on their own deliverables to develop and maintain a product.