Design control means a specific way of planning and executing medical devices or projects. It’s a combination or sum of laws. There are different parts of the design process. Each part can have detailed documentation or multiple portions can be…   Read more»

In many countries the design control standards are different. While in the US FDA follows ISO code regulations. On the other hand, there are different standards settled by other countries. Though there is a huge geographic and immune difference, most…   Read more»

Statistical sampling used in Control Quality. It is defined as selecting part of a population. The samples are chosen and tested according to the quality management plan. When doing this particular project management technique, the sample size and frequency should…   Read more»

I completely agree with the statement @cem34 made, though the reasonings are different in my opinion. Validation doesn’t signify real-time functionality rather it ensures the efficacy of a product based on user input. On contrary, verification denotes inspection of a…   Read more»

“Human factor” plays a crucial role in design verification ethics. Along with verification and validation, there’s a term called Human Factor which means, evaluating a device’s user interface to confirm that the device can be used safely and effectively by…   Read more»

I would like to talk about the verification protocol imposed by FDA on Surgical masks. Inadequate fluid resistance, Inadequate barrier for bacteria, Inadequate air exchange (differential pressure), Flammability, Inadequate respiratory barrier for bacteria are some of the tests needed to…   Read more»

Since there are two types of risks involved, their difference would enable us to solve them. Cost risk, schedule changes, performance and quality risk are listed as internal risks. Cost risk means risks of project costs being exceeded due to…   Read more»

Though risk management certainly has some advantages and benefits, there are some disadvantages too. If we think about automated risk management information systems that will make my statement more clear. It is not suitable for all kinds of organizations. Firstly,…   Read more»

There are many tools that can be used to mitigate the risks. Some of them are being discussed in risk management lectures. Mainly three tools have been mentioned. Among them first one was FMEA. FMEA stands for failure mode effects…   Read more»

From the lecture we know, there can be three different types of organizations where tasks are performed in three different ways. Project teams can be formed based on the employee’s skillsets, availability, or compatibility. Though there are certainly some downsides…   Read more»

We have known from Dr. Simon’s lecture, upper management is strategic, while middle management is tactical. Upper management is concerned with the growth of organization in the upcoming years, while the middle management people take care of the nitty-gritty things…   Read more»

I do have different opinions than @naglaa. For startup medical device companies I would highly recommend matrix organization over functional and project-based organizations. In functional organizations, there are silos between departments and I believe that harms the performance. Similarly, in…   Read more»

According to me, there are many advantages of written contracts over verbal ones. Some of the reasons are mentioned below:01. A written contract lays out the terms of the agreement which limits any of the parties to  claim anything otherwise.  …   Read more»

In this week’s lecture, Dr. Simon mentioned some laws which restrict physicians to receive gifts from companies.  The laws are Anti-kickback Statutes and Advamed Guidelines.  I agree with Naglaa. I am from the same area, where pharmaceutical companies highly influence…   Read more»

Posted by: @jaf22 Consultants in my company or my previous company have been useful in bringing expertise where our group lacks or needs a third party view. For instance, my company had a large acquisition that needed some smoothing of…   Read more»

Though incentives are offered to attract participants to join clinical trials, candidate selection plays an important role in accomplishing a successful research study. Therefore, picking randomized contestants and performing double-blind procedures will help minimize the selection bias. A double-blind study…   Read more»

Double-blind studies mean neither the experimenter nor the participant has any clue about the study or treatment. That helps to get the best possible results out of the experiment. Since the experimenter is also clueless about who is receiving the…   Read more»

Clinical research is significant in determining the safety and effectiveness of medications and medical devices. I agree with the above posts that discussed different aspects and the importance of clinical research on human trials. Undeniably, there is always a possibility…   Read more»

I would have chosen marketing over sales as a Biomedical Engineer. The marketing manager has to deal with all the departments present in the company like R&D, Operations, Quality Assurance, Management, Sales, etc. Since engineering people do have sound technical…   Read more»