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Forum Replies Created

RE: Written Agreement v/s Verbal Agreement

Although there’s not a substantial difference between verbal and oral agreements, there are some notable differences to note. Verbal agreements are classified as those that are through any form of com...

In forum Consultants and Legal Basics

6 months ago
RE: NDA vs Patents

No, an NDA is not a substitute for a patent. An NDA is an agreement that protects confidential information between business when collaborating. It is a temporary agreement that requires resigning ever...

In forum Consultants and Legal Basics

6 months ago
RE: Confidentiality Agreements

When finalizing a consulting agreement, it is important to clearly outline the expectations of the services provided by the firm, a timeline of when the service will be completed, and the payment deta...

In forum Consultants and Legal Basics

6 months ago
RE: Process FMEA (PFMEA)

I am currently interning at a biomedical equipment manufacturer, and we use PFMEAs for all of our products, as per ISO 13485. The PFMEA of each of our products contains valuable risk management inform...

In forum Risk Analysis for Medical Devices

6 months ago
RE: Risk Management

A risk assessment consists of a risk analysis, which identifies potential hazards, and a risk evaluation, in which each hazard is evaluated in terms of its probability and severity. Risk assessments a...

In forum Risk Analysis for Medical Devices

6 months ago
RE: To risk manage or not to risk manage?

The entire medical device development process, including the planning phase, has been carefully and strategically structured to minimize any unnecessary time or finances spent. If anything, risk manag...

In forum Risk Analysis for Medical Devices

6 months ago
RE: Validation vs Verification

In the development phase of product development, the process of verification occurs. This process verifies that the product aligns sufficiently with the requirements in place. The process includes a v...

In forum Introduction to Design Controls

6 months ago
RE: Consequences Of Insufficient Design Controls

Insufficient design controls can have negative repercussions on many aspects of the medical device industry, such as creating unnecessary costs, high defect rates, and in extreme cases, a company can ...

In forum Introduction to Design Controls

6 months ago
RE: Minutes for meetings

Meeting minutes are essential for staying on track with a project and being able to recollect information. I have used meeting minutes for numerous courses and clubs I have been involved in on campus....

In forum Introduction to Design Controls

6 months ago
RE: Clinical Research Experience/Course work for Biomedical Engineers

I think it is a great idea and highly beneficial that students spend time in a clinical setting to learn about the field's needs and shortcomings. Getting actual experience in a clinical setting would...

In forum Clinical Research Basics

7 months ago
RE: Diversity and Inclusion in Clinical Trials

Inclusivity in clinical trials is such an important concept, as it benefits not only the research, but also a diverse pool of participants. It's unfortunate that previous research trials have been mor...

In forum Clinical Research Basics

7 months ago
RE: Clinical Trial Participation

Clinical trials often offer its participants benefits of some sort, whether it be monetary compensation or some sort of personal health benefit with access to experimental therapies that may treat the...

In forum Clinical Research Basics

7 months ago
RE: Brand Coloring

A lot of medical device companies seem to use blue for the coloring of their logos, which is supposed to signify trust and strength within the brand. Of course, other medical device companies use diff...

In forum Marketing and Sales

7 months ago
RE: Business Minor/Major

For an aspiring engineer with little interest in future management positions, a business minor isn't particularly necessary, but in any case, I do not think that it can hurt. Working in industry has s...

In forum Marketing and Sales

7 months ago
RE: Marketing Clinical trials And Recruitment

Maintaining a diverse demographic across clinical trials is beneficial not only for collecting efficient data, but it is also advantageous in the sense that people across all backgrounds are given opp...

In forum Marketing and Sales

7 months ago
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