@rachel, I do not believe a guardians medical decision counts as a verbal agreement as the doctor/hospital is seeking consent to perform an emergency procedure rather than exchange goods. in the case that the procedure is not an emergency, a…   Read more»

I believe risks should be handled differently depending on how critical the part of the device the risk is associated with. the most critical parts will likely be handled with acceptance or transference regardless of the risk level, unless the…   Read more»

I mentioned in the Risk management meeting thread of a system to follow when brainstorming for potential risks During the brainstorming process identifying risks, priority should be placed on the risk of the most critical parts of the device that…   Read more»

while many have mentioned FMECA as the main tool for identifying risk, I believe during the brainstorming process identifying risks, priority should be placed on the risk of the most critical parts of the device that cannot be avoided, followed…   Read more»

China is one country with a comprehensive design control system regulated by the Chinese Food an Drug Administration(CFDA). since 2013 the CFDA has been revamping their medical device controls. in march of 2015 the CFDA “revised [their] Good Manufacturing Practice…   Read more»

I did my Bachelors at Long Island University, Brooklyn where I did subject based research. while devices were used, the purpose was to test the effects of the activity on the subjects rather than the efficacy of a device. many,…   Read more»

With any clinical trial, the ownership of the intellectual property will be established in the contracts between both employer and employee and between the sponsor and any contracted assistance. I think the IP should belong to which ever party owns…   Read more»

I can understand clinical experience being desired for an investigator, however research experience and good communication/people skills seem to be more important. While clinical experience icludes patient interactions and the administration various treatments, unless completion of the trials requires some…   Read more»

Fresenius Medical Care Vision Statement: “Creating a future worth living. For patients. Worldwide. Every Day.” “About four decades of experience in dialysis, innovative research, the global leader in dialysis services and products – that is Fresenius Medical Care. Patients with…   Read more»

Music videos are the prime location for many tobacco and alcohol brands that do not typically run television advertisements. While these music videos are showed on cable and satellite video channels, most of its views occur on youtube. this is…   Read more»

Another way companies utilize participation is with crowdfunding. Companies like Kickstarter have allowed companies, usually startups, to run a ‘campaign’ to fund a product. the ‘backers’ are treated as ground floor contributors and are encouraged to feel some kinship with…   Read more»

to elaborate further on what Ibraheem stated, the biggest difference between s-corps and c-corps is that unlike c corps, s corps income is passed through so taxes are only applied directly to the owners, rather than c corps taxation both…   Read more»

A company’s success is not dependent on whether or not it is publiclt traded. In fact the decision to go public is usually made based on how the owner(s) is/are seeking to profit. Many business owners make their fortune by…   Read more»

If you are looking to continue to build your company privately, an LLC is a good option. Because LLCs are passed through entities they are only taxed only once. Also with an LLC you get the Liability protection of a…   Read more»

While it may be true that some “current intervention practices de-incentive quality”, FDA regulations are intended to prevent harm to the device user, not to ensure quality. It is up to the discretion of the company to produce a product…   Read more»

I agree with dbonanno1 and dag56 on the integration of R&D and quality. by having R&D Engineers work in conjunction with Quality during the design process, delays can be minimized as procedures can be done properly the first time. it…   Read more»

For everyday tasks, “its too much work” is never a good reason not to do a particular task. the same applies to QA/QC systems. while these systems can be quite onerous to maintain, I think most people would rather good…   Read more»

Its not just Dietary supplements that the FDA needs more regulation on. some prescription drugs get to market unapproved. when the FDA finally gets around to getting these drugs off the market, the companies are given a long period of…   Read more»

although the FDA will potentially have more money in the long run, the delay in negotiation for a new deal will cause “substantial layoffs at the [FDA]” as the article Alexandra posted stated. this will definitely slow down review time…   Read more»