An NDA protects non-public information. The factors to consider while executing a Non-Disclosure Agreement may vary from a project-to-project. The main factors being ‘What information is considered confidential’ here the definition of confidential information should describe the type of information…   Read more»

In my opinion it is fair enough and not too restrictive because the law is enforced only after there have been cases where the physician was easily bribed to sell their product and make a huge profit. The physician will…   Read more»

A written contract obviously has an advantage over a verbal contract. The terms Verbal and Oral contract can be used interchangeably and mean the same. A verbal contract is a contract that in which the terms of terms and the…   Read more»

I believe I would like to work in a matrix based organization as it gets the team members and managers to work on a specific goal. There is quick flow of information throughout the project which results in an increase…   Read more»

We had our first in-person meeting the very next week Friday our project team was formed. We have decided to meed every Friday evening to check our progress on the project and help each other by having inputs from everyone…   Read more»

When given a choice to be able to choose a project team, which mostly happens in a matrix organization the project manager would like to choose a subject matter expert from the departments needed for that particular project to form…   Read more»

I would choose acceptance for low severity of risk as this is a good strategy to use for very small risks that won’t have much of an impact on your project if they happen and could be easily dealt with…   Read more»

In the medical device industry risks are identified by the residual safety risk zone for each risk identified to determine it’s acceptability. They may be identified into 3 zones. Zone 1 is when the risk are usually acceptable and do…   Read more»

In my opinion risk management meetings are successful when there is a full participation from all the members of the team. Brainstorming becomes easier and inputs from all the members helps consider the different risks which one might have not…   Read more»

Deign Control problems seem obvious only after adverse events, before that they are not so evident. Not starting out with a set of product requirements and do a top-down design the way the FDA expects is another factor that causes…   Read more»

In my opinion it will be beneficial if a particular pattern is followed while making a Gantt chart. Having the dates displayed right at the top for individual tasks apart for the entire project start/end date, while having the tasks…   Read more»

Verification and Validation are two different processes where validation follows verification. Verification is where you test/verify that the design outputs match your design inputs. It can include tests, analyses and inspections. Verification is typically making sure that you have objective…   Read more»

Design Controls are a part of 21 CFR part 820.30 which are presently adopted into the ISO 13485:2016 standard to ensure that the device or the even a component that you are making follows the design control process as it…   Read more»

I guess the sources of design input will depend on a number factors such as the customer requirements who can be doctors or patients, safety, similar designs from previously manufactured devices and their designs, market research and so on. After…   Read more»

Minutes of a meeting are essential. They contain the important points discussed in the meeting. It contains the necessary action items and the assignee for the action item which one would tend to forget after the meeting has ended, but…   Read more»

I would like to work as a Clinical Quality Assurance Auditor (CQA) who is responsible to ensure that the trials are performed as per the guidelines and regulations considering the various GxP practices such as Good Clinical Practices (GCP), Good…   Read more»

Clinical trials are meant to find new ways to detect, prevent, treat diseases or make an improvement to an existing drug or device. New methods/procedures are not possible without clinical trials.                   …   Read more»

I feel that a placebo-controlled study is important and valid. The purpose of the study as we know is to understand the effect of  treatment that do not depend on the treatment itself. The control group and the group of…   Read more»

Color is very important in branding and marketing because it is where the first impression of the customer lies. Colors convey emotions, experiences and feelings more than being just a visual aid. Colors and shapes are an immediate way of…   Read more»

The most memorable advertisement I remember was around 10 years back of Tide detergent on Indian television channels where a man walks using high sticks to walk on the road wearing a white shirt to avoid dirty water splashed by…   Read more»