Last seen: May 2, 2021
According to ISO 14971, the principles for Risk Management requires that risk be reduced as low as reasonably-practicable. The primary objective of th...
Risk-Benefit analysis is one of the central features of Risk Management. It is one of the most important principle in the ISO 14971. In September 11, ...
There are lots of tools and methods used in managing risk. That been said we do not want to confuse “ways on how to deal with risks” with the actual t...
Design control been included into the ISO regulation was a big plus. This has enabled medical device companies in other countries to have a set standa...
Just like the Human Repeat Insult Patch Test (HRIPT) is carried out in clinical study and on product (mostly OTC) just to see if any allergic reaction...
The Business requirement document I will say is the combination of the Design Input Documents (DID) and the Design Specification Documents (DSD). Busi...
Outsourcing your Device to another manufacturing company, there are a lot to consider before making such a decision. It comes with it's Pros and Cons ...
Both the DID and the DSD work hand in hand with each other. Without the DID you can not get the DSD of the Device. I like to look at this from the ...
With the ISO Adopting the Design Control, the EU regulatory which follows ISO regulation will have to accept ISO 13485:2016 for Design Control into th...
Personally I have always have the flare to go into research and also, Quality which am presently into. So for me I would love to be an Investigator wh...
Having interacted with an uncle who has a degree in Biochemistry and MSc in Environmental Change and currently a Clinical Research Associate (CRA), I ...
Clinical Trials are very essential both on medical devices and on drugs. The main purpose isn't to find the cure to all diseases. The main purpose of ...
Emotional Intelligence (El) is defined as a type of social competence involving the ability to monitor one's own and others' emotions, to discriminate...
A Mission Statement defines the company’s business, its objectives and its approach to reach those objectives. A Vision Statement describes the desire...
I haven't really used Participation in marketing or experienced it either or any of the other 4 Ps as stated. But with the lecture on it and also maki...