LLC protects you from the personal risks involved if a lawsuit were to arise concerning your business — safeguarding your personal assets. LLC gives flexibility in management and taxes are not paid at...

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 corporate taxes, the owner pays personal income tax on ...

I did research on Stryker, I found: SYK Gross Profit Margin (Quarterly) Range, Past 5 Years: Minimum 64.47% Maximum 68.29% Average 66.37% Net Profit Margin (Quarterly):12.98% Return on ...

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 exactly what an auditor will ask, you can use the obje...

Hi everyone, Let's talk about how you can improve quality control department? Without quality control procedures, you could face product recalls or safety hazards that lead to expensive litigation.So,...

Quality costs are the all the costs that a manufacturer incurs to ensure it produces a quality product. Quality costs to prevent low-quality production costs and costs that arise after a low quality p...

Also in 2016 the FDA recalled Dexcom G4 Platinum and G5 Mobile continuous glucose monitoring system receivers, due to complaints that the audible alarm may not activate the receiver when patients expe...

An example of a combination product: Bone morphogenetic proteins (BMPs) are a class of proteins that induce bone formation. New technology in orthopedic repair combines BMPs with a carrier matrix to c...

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

I found some examples of mobile medical applications the FDA has cleared or approved since 1997 from this link , also, FDA regulates mobile medical apps so Consumers can use both mobile medical apps ...

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 in order to test new medicines or treatments. Wit...

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

In general,to make sure you were successful with your end product: -Set measurable objectives for how product adoption will be achieved by customers during and after the product launch and determine y...

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 points in the client / agency relationship. Project...

I graduated from Electrical Engineering and currently I work in the medical imaging technology,(CAT scans,MRIs, nuclear cameras,...), I love this field.So, I decided to get my MS degree in BME.I find ...