As others have mentioned a written contract is a legal binding document, where you have signed pen to paper. Certain clauses allows to you to break from it, but if you there are any agreements in the contract that you go against, it can be held against you. In terms of an oral contract, it can be harder to go to court without any evidence. If you…[Read more]

In a company setting, working with someone you have a good relationship with always does helps tasks move faster to get things done, but I do not believe you should look away at an individual who may be more competent but you may not get a long with them. In a company, everybody is a professional and would act as such. In the end, you are all…[Read more]

I believe, if first starting up a company, such as a start up and do not want to have the corporate feel to the company, I believe an organic organization structure makes the most sense to start off. You have your three main positions of CEO, CTO, COO and then other positions follow under but it is still an open environment with continuous…[Read more]

In my current company, the organization type is a mix between functional and a project based organization. There are individual departments ranging from Hardware Eng, Quality, Software Eng, Systems Eng, Marketing, and Manufacturing. There certainly are silos, but for those of us in the R&D group that are not working on the on market product, there…[Read more]

In the current company I work at, we identify risks through a PHMM or Product Hazard and Mitigation Matrix. In these meetings you have directors from R&D, Quality, Manufacturing, and the Medical director discuss the potential applicable product risk management plan. To maintain and organize the risks each description of the harm or…[Read more]

Some other tools that I have seen used in risk management is root cause analysis. This allows us to pinpoint the factor or cause of the failure to help resolve and analyze how to stop it, how to prevent it from occuring, and what to learn from it. There are several methods to this including:
– Pareto Analysis
– Fault Tree Analysis
– Current…[Read more]

Design review meetings consist of many things. They review updates and changes that may be necessary and make a decision on said decision. Usually in these meetings you have a representative from each department, such as Quality, Regulatory, Marketing, and R&D. These changes or update to the development of the product consists of inputs from all…[Read more]

I actually just wrote and performed both verification procedures as well as validations for the current company I work at. FDA does not mandate a specific way verifications are performed, they just mandate in their 510k or PMA submissions that in verifications, design outputs meet the design inputs. Verification must verify each requirement and…[Read more]

Meeting minutes are a very important part of the design change process of the device and development as well. It depends what stage you are in the the medical device development cycle, that certainly dictates the importance of the meeting minutes. When design changes occur or design review meetings, and changes are implemented it is important to…[Read more]

I agree as well with the comment above, that if to choose a certain aspect that is important in the design development plan, the scope management plan is quite important. This details the ideas of the medical device and each milestone that should occur throughout the research and development of the product. The scope management creates a timeline…[Read more]

The reason design controls fails is because either procedures are not followed or the procedures themselves are poorly written, and the planning of every aspect of the device and documentation is poor. However, in a medical device industry that rarely occurs when design controls are inefficient. The FDA is very strict with its guidelines and…[Read more]

To add to the previous response, design verifications and design validations are very similar however, design verifications verify the design inputs and outputs. Design validations check that the user required specifications are met, and the that the medical device is validated for its intended use. Design verifications occur through in house…[Read more]