ISO 14971 regulation is directly co-related to with Risk Management, a system implemented to identify hazards and initiate a preventative action to ensure the medical device meets the regulatory requi...

Validation is important to determine if the device meets the user needs and it's intended uses, it helps the company determine if they are designing the right device. The FDA heavily focuses on Valida...

Design controls are an integral part of the success of any product, from the quality, performance, safety, reliability, performance standards and physical characteristics. Design controls looks into t...

Design Controls are not needed in the EU regulations, because they view a "snapshot" of that given point in time of the life of the device, they are searching for issues that could be present. The Tec...

From my previous experience with working with a team of engineers for a new product development, creating a Gantt chart is important at the early stages of the planning process. This chart helps ensur...

As many have discussed previously, meeting minutes are very important when it comes to documentation on when decisions are made, this helps the team know who is held accountable if something were to g...

Another country to heavily regulates medical devices such as their design controls is Japan which falls under Japan's Pharmaceutical and Medical Device Agency (PMDA) and works in conjunction with the ...

I would choose to work as a Clinical Quality Assurance Auditor (CQA). CQA inspects the documents and processes clinical trial data and ensuring the testing follows proper guidelines as stated by good ...

I would agree with most of the pointers that are mentioned above. When it comes to the discussion of clinical trials are ethically correct, one should also consider that for most people that are in un...

Based on my experience in the medical field as an EMT and as an Engineer, I can see how having a clinical background is paramount when it comes to working with doctors and other health care providers....

Emotional intelligence is very important for companies to understand because it focuses on the customer's emotions whether they are desiring to buy a product and what their current needs are. As discu...

Clever ways companies are venturing out to their customers or potential customers is via social media. Social media over the course of recent years has become a large platform where companies can comm...

Diopsys Mission Statement: Diopsys, Inc. is a medical instrumentation company dedicated to advances in preventive health care. The company specializes in the development and marketing of easy-to-use, ...

It all depends on the given goal in mind or the business when it comes to LLP vs LLC, if you see a large future for your business and expand to other states then an LLC is a better option, a larger wo...

I did research on Google the following are my findings: Net Profit Margin (Q2)= 13.55% as of June 2017 Net profit margin is the percentage of revenue that was brought into the company as profit. Compa...