I believe that their are great positives that come with this Act, but also some negatives. Two factors which should largely be considered at play in this case is the risk severity associated with the ...

Like Anthony said, need may also be a driving factor for individuals to enroll in clinical trials. One other form of compensation may be trials which are low risk but the method at which they are perf...

For me personally, I would elect to be a Clinical Quality Auditor (CQA). This is the individual which is responsible for verifying that all records are in compliance with the set standards and guideli...

Generating interest for a product before it is released is difficult to do if you are a medical device company, with respect to the consumer side. Attracting the attention of investors, and perhaps B2...

Personally, for me I am just starting out and would prefer to gain more time as an engineer before switching positions later in my career path. I believe that someone who has had a few years as an eng...

In this hypothetical company, for the sake of clarity we will name it BioStents. BioStents is a privately owned company based in the US, and is primarily focused in R&D, in which they are developi...

Two well-known medical device companies are Medtronic and Stryker. Medtronic's market cap is $168.59 billion and Stryker's is $99.43 billion. Therefore, both are massive companies in the space and eac...

Hi Hodafattel, I believe you have a point here in that life saving technology are being milked for their maximum value. From a business perspective, the company is doing exactly what they are supposed...

Due to the advantages and disadvantages of s-corporations and c-corporations there are suitable for different types companies depending upon their case. For instance, should someone create a corporati...

Pulling up the results of many job descriptions when applying you'll find many postings look for a candidate which has experience and understanding in root cause analysis (RCA). In essence, this is a ...

Many have mentioned above the implementation of new technologies such as AI will help measure dimensions and automate processes. This in turn will help and rapidly increase production, since a compute...

Quality assurance and quality control are two sides of the same coin. The focus revolves around quality of the product, and for medical devices, this can be vital. Having a defect occur in a product c...

@jwashin3 Your post here is very insightful as I did not know there was a MASSIVE change regarding what is a 510(k) in recent years. For others who want read the exact details on the amendment, the n...

I think one interesting point that this thread has not mentioned is how the pandemic has worsened the backlog of device awaiting approval due to the delays in inspection. According to medtechdive, the...

ISO 9001:2000 and the FDA's 21 CFR Part 820 draw many parallels. Both of these two regulations deal with the quality of product's and how they are produced. The FDA's regulation is part of CGMP (Curre...