I agree that the risk analysis is team based and involves checks along the way. The team should begin with a thorough identification of all potential and/or known hazards and develop an estimation of the risk(s) for each hazard. In a three-tiered version, the severity, probability of occurrence, and detectability of each hazard are evaluated,…[Read more]

According to the ICH Q9 Guidance, the risk assessment decision tree is the same in medical devices and pharma. Interestingly, in addition to the FMECA as mentioned in the lectures the Fault Tree Analysis is used as a risk management tool. The FTA tool (see IEC 61025) is an approach that assumes failure of the functionality of a product or process.…[Read more]

Hi Grzegorz, it is true like you have said that design control is important in order to ensure quality and correct errors. It is also important to note that design controls are required for all Class II and Class III medical devices developed in the US as part of the Quality Management System (QMS) and IDE. Also, it is important to note, that…[Read more]

I agree that in certain instances, it could benefit the company to outsource the design transfer. For one thing, it is more cost effective. If the vendor follows all the specifications and is trained well than effective design transfer can lower material and production costs, decrease product time to market, increase product quality, and generate…[Read more]

Thank you Himang for the great question. I don’t have experience conducting design review meetings. But from experience in review meetings as a whole, I can say it is best to keep the number of invitees medium sized since when too many people are included sometimes the conversations can be unproductive. Usually teams consist of one representative…[Read more]

Thank you Himang for the great question. I don’t have experience conducting design review meetings. But from experience in review meetings as a whole, I can say it is best to keep the number of invitees medium sized since when too many people are included sometimes the conversations can be unproductive. Usually teams consist of one representative…[Read more]

Although I agree with you Murad on clearly establishing roles and responsibilities, I think that the scope is also important to acknowledge early on in order to make sure the team stays on track and doesn’t veer off course. Working out of scope can also cost the company a lot of money and resources by missing deadlines of the DDP. As someone else…[Read more]

I would have to disagree that I don’t think there is any one aspect of the Design Development plan that is more important than the other. In order to produce a high quality product there needs to be good communication and the team members have to make sure they work within the scope of the project.

I agree with the statement that one of the flaws of design transfer occurs when there is an issue in transition of a product design to manufacturing environment. In order to ensure that the design of the medical device can be correctly translated into production specifications, particular care should be taken when the product involves new and…[Read more]