Forum

bsk32
@bsk32
Eminent Member
Joined: Sep 3, 2024
Last seen: Feb 9, 2025
Topics: 0 / Replies: 48
Reply
RE: Risk Management Tools

The FMEA is most valuable when determining the risks on a device. It can detect additional failure modes that add to the list of possible risks. It de...

3 months ago
Reply
RE: Risk Management in the Manufacturing Process

I agree that risk avoidance is the best way to deal with any level of risk, especially in manufacturing. However, mitigation tools and acceptance crit...

3 months ago
Reply
RE: Residual risk during device development

To determine the acceptable level of risk, it's important to follow the Risk Management Process. First, do a Risk Analysis and Estimation to list the ...

3 months ago
Reply
RE: Feeling Safer?

Hi elm33, After this week's lecture, I feel a lot safer knowing about Verification/Validation. These steps are there to catch flaws early on, and if...

3 months ago
Reply
RE: Validation vs Verification

Verification tests whether design outputs match design inputs. Validation tests whether design outputs satisfies user needs. In my previous job as a Q...

3 months ago
Reply
RE: Effective Use of Design Transfer in Streamlining Production for Medical Devices

One way to improve design transfer is to implement the use of CAD drawings so manufacturing can better understand how to make the product. This can in...

3 months ago
Reply
RE: Design Output

Companies will have Design Input and Design Specification documents in their DHF. They might not have a Design output because the Design specification...

3 months ago
Reply
RE: Benefits of Software Validation

Software Validation has many advantages. Software validation ensures that the device meets regulatory standards. This makes for quicker regulatory app...

3 months ago
Reply
RE: Validation's Role in Quality Product Development: Insights and Challenges?

Validation is very important to ensure that the costumer needs are met. This may involve using Human Clinical Trials. This is a step further that Desi...

3 months ago
Reply
RE: Placebo Effect

Placebo affects do not negatively impact a clinical trial. The Placebo group if compared with itself before comparing with the treatment group. Over m...

4 months ago
Reply
RE: Benefits for Patients in Clinical Research

I believe that in some cases it's ok, where in other cases it's not. In the case of a drug that required an IDE, it might be a good incentive just in ...

4 months ago
Reply
RE: Double Blind Vs Single blind Study

In a double-blind study, both the Investigator and Patient don't know whether they're being given the placebo or actual results. In a single-blind stu...

4 months ago
Reply
RE: Building marketing trust in medical devices: healthcare providers vs patients

I agree that providing clear evidence based data on safety and effectiveness is important for doctor's and patients. I think that patients want to fee...

4 months ago
Reply
RE: Difference between Product Development and Product Management

Product development is mainly responsible for research and development of devices. They are preoccupied with testing prototypes and designs for either...

4 months ago
Reply
RE: How Sales and Marketing Works

I agree that Sales and Marketing are important for Medical Device companies to meet the needs of costumers and deliver their final product to them. Ma...

4 months ago
Page 2 / 4