Currently i do not have any experience when it comes to the legal area. I agree with Dr. Simon’s recommendation on organizing a plan when meeting with the legal department either in-house or with another institution. This type of planning…   Read more»

Participation as mentioned by srg36, it is important for a company’s marketing strategy in the sense that it creates a welcoming feeling for new customers and shows that the medical device company is always open minded to hear to suggestions…   Read more»

Currently I am working in a medical device company that focuses on vision electrophysiology. The overall purpose of these vision testing systems is to aid optometrist and ophthalmologist diagnose their patients and use these devices for early detection. The two…   Read more»

Verbal agreements are usually not used or in this case highly not recommended, this is because in the legal world, if it isn’t written down and notarized, verbal agreements cannot be used for legal reasons. Anyone can make promises but…   Read more»

Policies like those restricting to provide certain payed services to physicians for example is important to understand why they are established and practiced. These policies i believe are set to prevent corruption and biased opinion to the product. As mentioned…   Read more»

Overall the course was very informative and provided insight on the jobs available in the medical device industry. My current interest is to work in R&D, learning about the regulatory and quality sections of the medical device development process was…   Read more»

Working with certain people that you have a good relationship is always a good thing to have when it comes to getting work done and brainstorming ideas. The problem here is that there are moments where certain people become dependent…   Read more»

Currently, I work in a functional organization structure. I am part of the Engineering department when I report to VP of engineering and I am part of an engineering team. We work closely with R&D, Manufacturing, Quality and Regulatory to…   Read more»

I believe the following is what should be followed: 1) Low Severity Hazards: Should be mitigated but it can also be considered trivial or negligible, however it it is a common problem then it should be considered looked into because…   Read more»

I agree that Risk Management should be considered a living document to help a company document and keep track of their product post production. There are some issues that a product can experience after production their complaints can help a…   Read more»

ISO 14971 regulation is directly co-related to with Risk Management, a system implemented to identify hazards and initiate a preventative action to ensure the medical device meets the regulatory requirements. Risk management revolves between a Risk Analysis procedure and FMECA…   Read more»

Validation is important to determine if the device meets the user needs and it’s intended uses, it helps the company determine if they are designing the right device. The FDA heavily focuses on Validation where technically during the entire design…   Read more»

Design controls are an integral part of the success of any product, from the quality, performance, safety, reliability, performance standards and physical characteristics. Design controls looks into the inputs, outputs, validation, verification, and design planning, if there exists any poor…   Read more»

Design Controls are not needed in the EU regulations, because they view a “snapshot” of that given point in time of the life of the device, they are searching for issues that could be present. The Technical File and Design…   Read more»

From my previous experience with working with a team of engineers for a new product development, creating a Gantt chart is important at the early stages of the planning process. This chart helps ensure the team follows a timeline to…   Read more»

As many have discussed previously, meeting minutes are very important when it comes to documentation on when decisions are made, this helps the team know who is held accountable if something were to go wrong. Not only to help one…   Read more»

Another country to heavily regulates medical devices such as their design controls is Japan which falls under Japan’s Pharmaceutical and Medical Device Agency (PMDA) and works in conjunction with the Ministry of Health, Labor and Welfare to ass new product…   Read more»

I would choose to work as a Clinical Quality Assurance Auditor (CQA). CQA inspects the documents and processes clinical trial data and ensuring the testing follows proper guidelines as stated by good clinical practice (GCP). This role attracts my attention…   Read more»

I would agree with most of the pointers that are mentioned above. When it comes to the discussion of clinical trials are ethically correct, one should also consider that for most people that are in unique situations where a new…   Read more»

Based on my experience in the medical field as an EMT and as an Engineer, I can see how having a clinical background is paramount when it comes to working with doctors and other health care providers. I can say…   Read more»