Activity | asn99 | Medical Device Courses

asn9 replied to the topic "Discussion Topic: Your organizational type" – 5 years, 11 months ago

Hi All, Currently I work for a Matrix Organization. While I work currently as a Functional Manager because we are a start-up we work on many other side projects. This allows for many of the functional managers to become project… Read more»
asn9 replied to the topic "Risk Identification" – 5 years, 11 months ago

Hi All, At my company we have a similar setup as was mentioned previously: 1- Documentation Reviews 2- Information Gathering Techniques like Brainstorming, Delphi Technique, Interviewing, Root cause analysis 3- Checklist analysis – previous similar project, lowest level RBS 4-… Read more»
asn9 replied to the topic "Risk management and Labels" – 5 years, 11 months ago

I would agree with Dr. Simon that it makes sense why labeling would not be considered a strong way to mitigate risk. While warning and instruction labels are important, it is also up to the company to ensure that the… Read more»
asn9 replied to the topic "Risk analysis in real company" – 5 years, 11 months ago

Thank you very much for the interesting question. I would agree with Tarek that determining the risk associated with a project is a team effort. Each member of the team may be able to evaluate different risks with the device…. Read more»
asn9 replied to the topic "Making up tests for design verification and validation" – 5 years, 11 months ago

Hi Roberto, After doing some research, I was able to find that the FDA does not demand specific tests, but establishes guidelines for developing design controls, design validation, and design verification. Looking through the site briefly it seems that much… Read more»
asn9 replied to the topic "Minutes for meetings" – 5 years, 11 months ago

Hi Roberto, Thank you very much for your question. I would agree with Dr. Simon that meeting minutes are extremely important. I have been in meetings may times where tasks have been assigned and deadlines have been established. Oftentimes if… Read more»
asn9 replied to the topic "Design Transfer and Challenges" – 5 years, 11 months ago

Hi All, I wanted to elaborate a little on a point that was made about the difficulty of the purchasing department not not having enough time to identify and approve new vendors, as this can be a major difficultly in… Read more»
asn9 replied to the topic "Consequences Of Insufficient Design Controls" – 5 years, 11 months ago

Hi Lamiaa, Thank you for your questions and the examples provided by the others. I believe that one main issue that would occur is that the project would be extremely disorganized and would be greatly delayed. The different areas of… Read more»
asn9 replied to the topic "Important Part of DDP" – 5 years, 11 months ago

Thank you very much for your interesting question. I would agree with Tarek that it is difficult to choose which area of the DDP is most important, but the Gantt Chart is extremely useful. As Tarek mentioned, it really outlines… Read more»
asn9 replied to the topic "Discussion Topic: Supplemental on DHF and DMR" – 5 years, 11 months ago

Yes, Design Controls would be needed for a medical device in the EU. While there would be no DHF needed in the EU, most of the parts of design controls would still be needed, such as the: PDF, DDP, DID,… Read more»
asn9 posted a new topic "DHF vs. Tech File/Design Dossier" – 5 years, 11 months ago

Hi All, I was thinking about the differences that Dr. Simon highlighted in the lecture of the DHF vs. Tech File/Design Dossier. The DHF seems to be to be very complete and shows everything involved in the development, testing, and… Read more»
asn9 posted a new topic "Guidance Documents" – 5 years, 11 months ago

Hi All, After learning about Guidance Documents, I found them to be a very useful tool for getting devices approved in the EU. There are three groups that write guidance documents: MEDDEV Guidance Documents, NB-MED Guidance Documents, and Competent Authority… Read more»
asn9 posted a new topic "Legal Contracts" – 5 years, 11 months ago

Hi All, One problem that I frequently face at my position is working out contracts for research. Each side typically has their own ideas and pieces that they would like included. As was mentioned, management and especially academics are very… Read more»
asn9 replied to the topic Types of Clinical Studies in the forum Clinical Trials for Medical Devices 7 years, 11 months ago

Hi mjf34,

That is a really interesting example. I have always wondered what the negative outcome would be of attempting to complete a double blind study. However your example of the group becoming bias based on the experimental group and placebo group, ruining the double blind as well. I have always thought this would be the best type of study;…[Read more]
asn9 replied to the topic AMDD in the forum Clinical Trials for Medical Devices 7 years, 11 months ago

Hi All,

I would agree that both MDD and AMDD are very useful and practical classes. Working in the pharmaceutical industry, I even saw the great benefit. I believe that these courses, or similar ones, should be a mandate for students in the biomedical masters program as practical classes can be greatly beneficial. Having experience in other…[Read more]
asn9 replied to the topic Simulation Experience in the forum Clinical Trials for Medical Devices 7 years, 11 months ago

Hi All,

The thoughts above were great, and I would have to agree that I have learned much from the simulations. One of the main things was simply how to better work with a team in solving problems. While I experience this much at my current position, practicing with different people was a great benefit to myself. I also believe that thinking…[Read more]
asn9 replied to the topic Significant risk vs Non-significant Risk in the forum Clinical Trials for Medical Devices 7 years, 11 months ago

Hi All,

I would agree with the examples and the points given above. I believe that SR vs. NSR is really determined by a combination of the classification of the device and the application of the device. As was mentioned if a device is classified as a low class it may be a NSR. However if the device had an application that was more risky it may…[Read more]
asn9 replied to the topic Consent and predicted outcome in the forum Clinical Trials for Medical Devices 7 years, 11 months ago

Hi All,

I found that interesting as well. I believe the partial answer to your question is that there are unexpected results sometimes, even if extensive animal trials have been done. There can be cases where we would expect certain side effect, but in reality, they are much worse than first thought.

I looked up to see if there were any recent…[Read more]
asn9 replied to the topic CROs in the forum Clinical Trials for Medical Devices 7 years, 11 months ago

Hi All,

This is a very good question. I actually work with a company that helps Pharmaceutical companies to connect with CROs and I found it quite surprising how much they are willing to outsource through these companies. Many of them they have established relationships with for many years so they trust them with huge and extremely important…[Read more]
asn9 replied to the topic CAPA in the forum Quality Systems Management 7 years, 12 months ago

Hi All,

I would agree with the many point above made about CAPA. Since first learning about I can truly see why it is needed in companies to repair non-conforming products. It is really a system designed to prevent and repair issues as they arise. As was mentioned CAPA can be done on both a quality system and non-conforming product, allowing for…[Read more]
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