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 co...

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....

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 th...

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 resul...

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 havin...

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 ...

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 wit...

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 r...

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 t...

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...

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/...

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 te...

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 c...

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 t...

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 forg...