I agree with all of the methods mentioned but I believe the task analysis and error use analysis methodology is the best way to address usability risks. The task analysis helps to identify and document the environment in which the task is conducted, the operators involved, the information required to perform the task, and the sources of…[Read more]

I believe one of the most important mistakes mentioned was how risk management is not a life cycle process. It should be a living a document and updated accordingly. Complaints and feedback from the users should be heard; the market size is usually much larger than the risk management staff and could see potential risks that the company may have…[Read more]

For high severity of risk I would use mitigation and avoidance. A device with a high severity risk has the potential to kill or severely harm someone which is not only morally wrong but leads to huge lawsuits. It is important to avoids or mitigate these types of risks as they would cause the most financial loss to a company. I would use acceptance…[Read more]

I also had to do a business requirement document in capstone here at NJIT and I see the similarities between this and the design validation process. The business requirement document had us list all the costumer needs and make sure we fulfilled them. This is similar in that validation checks that the inputs are the user needs or intended use and…[Read more]

I also had to do a business requirement document and I see the similarities between this and the design validation process. The business requirement document had us list all the costumer needs and make sure we fulfilled them. This is similar in that validation checks that the inputs are the user needs or intended use and then validates whether the…[Read more]

Phase 1 clinical studies are done on a small group of participants after the drug or treatment has been proved safe on animals. Doctors use this phase to establish a good dosage range as well as collect data on the effects of the drug or treatment and its safeness. Clinical studies are a part of the validation process in design controls. If a…[Read more]

Phase 1 clinical studies are done on a small group of participants after the drug or treatment has been proved safe on animals. Doctors use this phase to establish a good dosage range as well as collect data on the effects of the drug or treatment and its safeness. Clinical studies are a part of the validation process in design controls. If a…[Read more]

As my classmates have mentioned the FDA does not demand specific tests for design verification or design validation. The FDA ensures good quality assurance practices with the 21 CFR Part 820.30 that Dr.Simon mentioned in his lecture. This regulation does not describe the practices that must be used but establishes the framework that manufacturers…[Read more]

AS sdl3 said, the Design Dossier or Tech File can be beneficial for audits as they only have to look back at the material that was updated since the last audit because of the new ‘snapshots’. I think this method can also be helpful if a product starts to fail after a change in design. One can easily compare the different snapshots and see where…[Read more]

I agree with what everyone has already said about inefficient design control leading to dangerous devices, lower quality, traceability of the product, or the FDA not allowing the product to get to the market. To add to all of this, design control is also a key factor in fixing any problems that arise. The Design History File (DHF) contains all of…[Read more]

As Dr. Simon said, the DDP is often just used as a boiler plate placeholder in the DHF but it should be used as an underlying plan for the project. Therefore, all of the 5 parts you mentioned are important. If I had to pick which was the most important I would narrow it down to quality management plan and team member lists/responsibilities.…[Read more]