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asimbana
@asimbana
Trusted Member
Joined: Sep 8, 2017
Topics: 0 / Replies: 61
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RE: Discussion Topic: Risk Management, Risk Analysis

ISO 14971 regulation is directly co-related to with Risk Management, a system implemented to identify hazards and initiate a preventative action to en...

7 years ago
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RE: When is validation is not required?

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 t...

7 years ago
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RE: Consequences Of Insufficient Design Controls

Design controls are an integral part of the success of any product, from the quality, performance, safety, reliability, performance standards and phys...

7 years ago
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RE: Discussion Topic: Supplemental on DHF and DMR

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 s...

7 years ago
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RE: Factors to Consider While making Gantt Chart

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 stag...

7 years ago
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RE: Minutes for meetings

As many have discussed previously, meeting minutes are very important when it comes to documentation on when decisions are made, this helps the team k...

7 years ago
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RE: Design Controls in the other countries

Another country to heavily regulates medical devices such as their design controls is Japan which falls under Japan's Pharmaceutical and Medical Devic...

7 years ago
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RE: Clinical Trial Roles

I would choose to work as a Clinical Quality Assurance Auditor (CQA). CQA inspects the documents and processes clinical trial data and ensuring the te...

7 years ago
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RE: Clinical Studies

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...

7 years ago
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RE: Discussion Topic: Having a "clinical background"

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 wor...

7 years ago
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RE: Discussion Topic: Emotional Intelligence and its affect on sales

Emotional intelligence is very important for companies to understand because it focuses on the customer's emotions whether they are desiring to buy a ...

7 years ago
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RE: Discussion Topic: The Fifth "P" of Marketing

Clever ways companies are venturing out to their customers or potential customers is via social media. Social media over the course of recent years ha...

7 years ago
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RE: Discussion Topic: Mission and Vision statements

Diopsys Mission Statement: Diopsys, Inc. is a medical instrumentation company dedicated to advances in preventive health care. The company specialize...

7 years ago
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RE: Types of Corporations

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 ...

7 years ago
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RE: Discussion Topic: Exercise your research skills

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...

7 years ago
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