LLC protects you from the personal risks involved if a lawsuit were to arise concerning your business — safeguarding your personal assets. LLC gives f...

In a sole proprietorship, the owner of the business and the business are a single entity. Only one person owns the company and instead of paying corpo...

I did research on Stryker, I found: SYK Gross Profit Margin (Quarterly) Range, Past 5 Years: Minimum 64.47% Maximum 68.29% Average 66.3...

To be prepared for an audit, you will need to periodically review your quality system records (DHRs) for these areas. While you can’t be certain exac...

Quality costs are the all the costs that a manufacturer incurs to ensure it produces a quality product. Quality costs to prevent low-quality productio...

Also in 2016 the FDA recalled Dexcom G4 Platinum and G5 Mobile continuous glucose monitoring system receivers, due to complaints that the audible alar...

An example of a combination product: Bone morphogenetic proteins (BMPs) are a class of proteins that induce bone formation. New technology in orthoped...

Here another example: No More 510(k)-only PMA required for all Automated External Defibrillators (AEDs) FDA has finalized a change in policy that wil...

I found some examples of mobile medical applications the FDA has cleared or approved since 1997 from this link, also, FDA regulates mobile medical app...

I consider it ethical to experiment on animals if the tests are done in the name of medicine.Experimenting on animals is often the best or only option...

When we test the biocompatibility of material especially for medical devices,there are some categories depending on final usages.As mentioned above, c...

In general,to make sure you were successful with your end product: -Set measurable objectives for how product adoption will be achieved by customers d...

Missing a milestone considered to be failure for your project.YES Its YOUR fault! for example, missing deadlines, this is one of the surest breaking p...

I graduated from Electrical Engineering and currently I work in the medical imaging technology,(CAT scans,MRIs, nuclear cameras,...), I love this fiel...