Forum Replies Created
RE: AI & IoT in medical device industries. It is clear from our class lectures that organizational development (OD) is very important in assisting medical device manufacturing companies to integrate cutting-edge technologies. In fields regardi... |
4 months ago | |
RE: Organization Type vs. Effectiveness Based off my experience in industry, I believe that the ideal organizational layout varies based on the company's objectives. A flexible approach such as "everyone does all tasks" is suitable for smal... |
5 months ago | |
RE: Upper vs Middle Management. I believe I have the potential to succeed in both positions in the long run, but I envision myself beginning in middle management. Middle management is primarily responsible for task execution and ens... |
5 months ago | |
RE: Forming a Project Team That's an awesome question! In order to build a successful project team, I feel that I must prioritize selecting members with the required knowledge and abilities for their respective positions, in ad... |
5 months ago | |
RE: Expense of Regulations Hi Savannah! Those are great questions. Compliance with ISO, FDA, and ASTM standards can be expensive as it involves a good amount of resources, expert cooperation, and continuous updates. Based off m... |
In forum Risk Analysis for Medical Devices |
5 months ago |
RE: To risk manage or not to risk manage? Risk management is certainly a crucial aspect of the planning stage, particularly in the area of medical device development. I worked in medical device development for quite some time and what I notic... |
In forum Risk Analysis for Medical Devices |
5 months ago |
RE: Risk Management Based off my experience working in a medical device company for dental implants, conducting a risk management evaluation for a medical device offers many important advantages! One of the most commonly... |
In forum Risk Analysis for Medical Devices |
5 months ago |
RE: Validation vs Verification @jt63njit-edu I absolutely agree with you. Verification focuses on making sure that the software meets the specified requirements through activities like inspections or even reviews. It is often refer... |
In forum Introduction to Design Controls |
5 months ago |
RE: Consequences Of Insufficient Design Controls Hi Saad, You make a great point that design control is crucial for any medical device development as it ensures that the item is safe, efficient, and compliant with regulations. There are definitely ... |
In forum Introduction to Design Controls |
5 months ago |
RE: Minutes for meetings Hello Roberto, While I understand where Dr. Simon and many of these posts are coming from, I would like to play devil's advocate and also recount a more negative aspect of meeting minutes. I have foun... |
In forum Introduction to Design Controls |
5 months ago |
RE: Corporate Responsibility? In the world of medical devices, I would imagine that companies take corporate responsibilities pretty seriously because patient safety and following FDA regulations are highly crucial. How companies ... |
In forum Introduction to Design Controls |
5 months ago |
RE: Capstone Project Proposals (Shortened PDF) My capstone project focuses on creating a chitosan based sulfated polysaccharide hydrogel for wound healing, specifically aimed at larger cutaneous wounds, including the potential for diabetic foot ul... |
In forum Introduction to Design Controls |
5 months ago |
RE: The Defines of Design Controls I agree with you that design controls are very important for ensuring the safety and efficacy in medical device development. They help in maintaining the structural approach that aligns with FDA requi... |
In forum Introduction to Design Controls |
5 months ago |
RE: Incentives for Clinical Trial Participants As I worked in research with a Veterans Affairs Hospital, one major incentive outside monetary compensation that was used was access to free medical care or treatments. The offer of free medical evalu... |
In forum Clinical Research Basics |
6 months ago |
RE: What if I told you... @atk27njit-edu I would disagree that the placebo effect is “all in the mind.” While the placebo effect does rely on expectation, it’s not simply a mental trick played by the mind. This is rather a rea... |
In forum Clinical Research Basics |
6 months ago |