jj52

  • From recent training received at my job we were always told that gifts shouldn’t be higher than $50 dollars and should be able to be shared with others within the company or benefit the tasks needed to complete our studies….   Read more»

  • jj52 posted a new topic "Advamed Guidelines"a year ago

    During this week’s lecture, Advamed guidelines were briefly discussed. One guideline that stood out to me was that sponsored held events must be held at a reasonable location. When thinking of places that might not been seen as a reasonable…   Read more»

  • jj52 posted a new topic "Verbal Contracts"a year ago

    This week, we learned about the legal basics in the medical device industry, one specific topic was the significance of both verbal and written contracts. Given that most contracts are required to be in writing, what strategies are used to…   Read more»

  • jj52 replied to the topic "Forming a Project Team"a year ago

    Maintaining a balanced working relationship is crucial. While prior experience with a team member from a past project can facilitate the initiation of a new one, it is extremely important to ensure that these individuals bring substantial value to the…   Read more»

  • Before addressing your question, I agree with your statement that being part of middle management can provide a solid foundation for an upper management position. Personally, while I am confident in my ability to succeed in both roles, I lean…   Read more»

  • After being assigned to our project groups about two weeks ago, which organization structure (Functional, project-based, or matrix organization) do you think will benefit your group and the device development? 

  • jj52 replied to the topic "Expense of Regulations"a year ago

    I actually questioned this myself this past weekend when creating the DID for the project Dr. Simon has assigned to us. Personally, I feel as though regulations should not cost since these regulations help ensure that devices are being designed…   Read more»

  • jj52 posted a new topic "Risk Acceptance"a year ago

    This week we learned of 4 ways to deal with risks: avoidance, mitigation, acceptance, and transference. After learning the difference between the four, d0 you think risk acceptance creates a higher probability of risk? If so, when do you think…   Read more»

  • jj52 replied to the topic "Hazard, Hazardous, Harm"a year ago

    I currently work in an in vivo lab and can think of several hazards in a hazardous situation with a specific harm. We often have certain test subjects that undergo doses of radiation and other test articles. The main hazards…   Read more»

  • @vnd4 If verification test usually stay in house, do you think there is a specific department or procedures that ensure that this verification methods are suffice? I’m aware that inputs and outputs must equal but how can we confirm that…   Read more»

  • jj52 replied to the topic "Document Corrections"a year ago

    This is sort of off topic of correcting specific documents such as DSD and DID but I wanted to mention the practices in Good Laboratory Practices (GLP) regarding data collection. In GLP, when errors occur during data collection there is…   Read more»

  • Device trials are different in several ways when compared to drug trials such as: 1) medical device trials are usually smaller than drug trials. 2) Physician technique or bias is a larger role in drug trials. 3) medical devices modifications…   Read more»

  • jj52 replied to the topic "Design Transfer"a year ago

    There have been lots of good points mentioned on the benefits of outsourcing or stay in house. The main point that was made is if it is cost effective for a company. I think staying in house is always more…   Read more»

  • jj52 posted a new topic "Document Corrections"a year ago

    During this week’s lecture different types of documents were discussed such as DID and DSD. When there is a error found in these different types of documents is a change request issued? Or are there other ways to correct.

  • jj52 replied to the topic "Minutes for meetings"a year ago

    I agree that meeting minutes are important and that people usually don’t pay as much attention as they should to them. I also think meeting minutes are more important to those who were unable to attend the meeting. Meeting minutes…   Read more»

  • jj52 posted a new topic "Placebo Effect"a year ago

    This week we have learned several different types of clinical studies. Throughout my elementary through high school education we were taught about placebo controlled studies and how patients may be subjected to a placebo effect. A placebo effect is the…   Read more»

  • jj52 replied to the topic "Clinical Research Studies"a year ago

    As mentioned above there is a negative denotation with clinical trials although there are regulations instilled that protect both the patient and researcher. It’s important to mention that everyone involved in clinical trials are informed of the risks and have…   Read more»

  • With my skillset I believe I could be successful in the role of a clinical research associate (CRA), a data manager, or even a quality associate (CQA). In my current position I am a research scientist and complete several studies…   Read more»

  • With my skillset I believe I could be successful in the role of a clinical research associate (CRA), a data manager, or even a quality associate (CQA). In my current position I am a research scientist and complete several studies…   Read more»

  • jj52 replied to the topic "Digital Marketing"a year ago

    The internet has changed marketing by making it easier to reach your target market and gain exposure for your business. Social Media platforms allows businesses to set up ads which are seen frequently when scrolling through and you can purchase…   Read more»

  • Load More