Posted by: @abhitrivedi1211 What factors contribute to determining values for risk index numbers. Two examples are 'how often the failure occurs'? and 'what is the severity of the failure?'. Some fa...

Posted by: @lmathis When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting? I do believe that once a device maker has wei...

What are some benefits of implementing a risk management assessment for a device? Give the pros and what can be seen as potential cons if there any?

Posted by: @fgk4 As we all have learned this week, a validation may not be required if:- There were no changes required to the product after verification.- A clinical trial is not required- Product c...

Posted by: @la82 As mentioned in other discussions, design control is an integral part of any medical device design, and its benefits are clear. However, what are some of the issues that arise of the...

Posted by: @hg93 “Design Controls” is a FDA term and defined in FDA 21 CFR 820.30. Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied...

Posted by: @jr377 This year, the Right to Try act was signed into federal law. This law allows patients to request the use of investigational drugs (without FDA involvement or state law). There was a...

Posted by: @alexandrabuga Background: Henrietta Lacks was a woman whose cancer cells were the source of the HeLa cell line, the first immortalized cell line and one of the most important cell lines i...

Posted by: @llefevre According to the National Institute of Health web site on clinical trials, there are over 225,506 studies currently being conducted throughout the United States and 192 countries...

Posted by: @amd29 Prof. Simon has made it simple; he seems to definei) Marketing: --- as being able to have the customer believe that what you - the marketing agent - areoffering is what they truly n...

Posted by: @srg36 I have a question about family businesses. Say for example someone started a sole proprietorship, and down the road the business grows and is successful, and that person wants to pa...

Posted by: @amandaally1029 What is the difference between public and private companies? Based on their differences, what are some pros and cons of each? Give an example of a private and public compan...

Posted by: @sahitya-sadineni Part of FDA's mission statement is providing safety and protecting the public health in the use of drugs, medical devices, and etc.. The second part of the mission statem...

Posted by: @sahitya-sadineni Precision and accuracy are very important to the scientific field. Accuracy is how close the value is to a standard while precision refers to how close the values are. Wh...

Posted by: @hruship101 Many departments such as Manufacturing or R&D tends to complaint that their quality department is so stringent in terms of documentation and the document control even if it...