All risk is valued by Failure Mode Effects and Criticality Analysis (FMECA). It is an approach to analyze risk. Certain factors that contribute to determining the risk values are how something can fail, the severity of the consequences, and the…   Read more»

As it was discussed in the slides by dr.simon, Risk management plan identifies and evaluates all the risk. One method that analyzes risk is by FMECA which stands for Failure Mode Effects and Criticality Analysis. Then documentation reviews take place…   Read more»

According to FDA, design control makes us demonstrate compliance with codes and it has nine parts. These nine parts are Planning, Input, Output, Review, Verification, Validation, Transfer, Design Changes, and Design History File. Each of these nine parts has their…   Read more»

Regarding the Gantt chart, I have yet to gain experience in the industry, but from my senior year capstone course, I do have experience in creating Gantt charts. A simple and basic essential you need to start the chart is…   Read more»

The purpose of doing meeting minutes is to have everyone on the team and everything related to the project straighten out in order. It helps you to remember what was discussed in the meeting, where did it happen, who attend…   Read more»

Similar to mentioned already, validation is the process of making sure that the objectives meet the user needs and intended uses have met. certain methods that verify these details are through inspections, clinical trials, and design analysis. After the design…   Read more»

Design Development Plan is certainly the crucial component in a project. DDP ensure traceability of design and development outputs and inputs to design. I think the quality management plan is more important than communication plan. The quality unit has the…   Read more»

Indeed, it is important that medical system companies design and develop a medical device that is safe and efficacy for the consumers to use. FDA, IND and other regulatory organizations want to regulate the product and assure that the medical…   Read more»

Blinding study was introduced to avoid bias in the evaluation of treatment effects. As you have mentioned, double blinding studies require blinding patient, who is unaware of which treatment is given and also blinding the investigator. Thus, it guarantee objective…   Read more»

Like you have mentioned, clinical tests takes place to evaluate the safety for human well being. Similarly, Pharmaceutical companies conduct clinical test to evaluate the safety and efficacy of their drugs. This tests are an important requirement to obtain regulatory…   Read more»

Placebo-controlled trials are used widely in the development of new pharmaceuticals. The concerns about the use of placebo-controlled trials are not uniformly unethical when known effective therapies are available, rather their approval is determined by whether the patient will be…   Read more»

In my opinion, manipulation is one type of marketing stimuli factors under persuasive technique. Emotive persuasion could be divided into non-manipulative and manipulative techniques. Many of manipulative marketing are difficult to prove because of their controversial nature and content. The…   Read more»

Agreed, color does play an important role in everything whether it is about restaurants, hospitality, products or brand name. Every color has their own meaning which represents the companies and their goal. Such as Going green uses Green or yellow,…   Read more»

Nowadays they are plenty of commercial/advertisement that contains humor, adventure, influencing etc message which are easy to convince consumers. Recently, I came across this old print advertisement of Duracell, where their message was “Some toys never die”. It was one…   Read more»

Like many of you said in here, the sole proprietorship has only one owner and it cannot be passed down to anyone even if it is a family member. However, there is always an option of buying the company father’s…   Read more»

I would definitely consider partnership for the business over a sole proprietorship. It is true that there are more benefits for a sole proprietorship then partnership but the partnership is what you should look for when starting a new business…   Read more»

This question is indeed an interesting one because I always think about doing a research on what the company is about before applying. I feel like all of us try to learn more about a company before applying. However, the…   Read more»

From my personal experience, audits are to making sure that everyone working in the company is familiar with the company’s goal and mission. Another main point is to expose everyone to SOP’s for their own department. Always have all documents…   Read more»

Document control can be improved by ensuring each department in the company is cooperative with other department and co-worker. The documents are to be completed and updated with the new regulations on daily basis. When there are changes to be…   Read more»

I agree with most of the people here, Quality can definitely be demanding for medical and pharmaceutical companies out there. It is the most important core factor in the high cost of delivering good quality products to the consumers. In…   Read more»