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mmd55
@mmd55
Trusted Member
Joined: Sep 3, 2021
Last seen: Apr 25, 2022
Topics: 16 / Replies: 64
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RE: To risk manage or not to risk manage?

I completely agree, risk management is crucial especially in medical devices. Working in an industry where, for some people, a product can mean life o...

4 years ago
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RE: Benefits of post-market surveillance

I think PMS is essential for medical device companies. One huge benefit of PMS is the ability to put a microscope to any product failures and identify...

4 years ago
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RE: Dealing with risk

I think that risk in medical device development is incredibly different than many other industries and is handled differently because of that. There i...

4 years ago
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RE: Customer Needs, Business Requirements, Test Plan

I have noticed, since taking senior design and working, that the test plan is very important. In terms of design documents, the test plan can help sat...

4 years ago
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RE: Customer Needs and Design Input

I think both documents are incredibly important. The documents you are describing detail the differences between verification and validation. Verifica...

4 years ago
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RE: Design Controls: What do you deem most important?

Personally, I think all parts of design controls are important but I think Verification and Validation are especially important. I work in bench top p...

4 years ago
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RE: Why VERIFICATION is important? and Your ideas to improve Verification process ?

Hi MerzKrashed, I completely agree that good verification practices can only benefit medical device companies and patients by a ensuring a device is...

4 years ago
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RE: Validation Types

In my line of work, one type of validation that is done is Test Method Validation. This is done to identify any variation that may be present within a...

4 years ago
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RE: Clinical Studies

I agree with you, I think clinical trials are necessary for discovering if a drug/biologic/device is safe and effective but sometimes they hold some r...

4 years ago
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RE: WHAT IS THE OBJECTIVE OF CLINICAL TESTING ON PHARMACEUTICA DRUGS?

I disagree with your statement that "pharma drugs have never actually improved the direction of human wellbeing". Clinical trials for medication have ...

4 years ago
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RE: Placebo-controlled trials: Are they ethical? Are they necessary ?

Placebo controlled trials are unfortunately necessary. During the sophomore year of my undergraduate degree, I was involved in research for children...

4 years ago
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RE: Fuzz before launch of product.

I think that companies like Verb and Ethicon market their upcoming products by using their name recognition (In Verb and Ethicon's case, Johnson and J...

4 years ago
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RE: Who Are You Selling To?

Medical device companies typically tend to market products to their primary consumers, doctors and hospitals. In the case of dental tools, oral surgeo...

4 years ago
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RE: Digital Marketing

@hodafattel I think you raise valid points about how the internet has changed traditional retail businesses, however, I think that there are some diff...

4 years ago
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