According to ISO 14971, the principles for Risk Management requires that risk be reduced as low as reasonably-practicable. The primary objective of the ISO 14971 is to provide protection primarily to ...

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, 2019, the FDA release some factors to consider whe...

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 tools or methods needed to manage or mitigate risk....

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 standard to work with. Thus, Design controls are mandate...

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 might have developed over the years. Also, the Hu...

The Business requirement document I will say is the combination of the Design Input Documents (DID) and the Design Specification Documents (DSD). Business requirement document just like what have been...

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 of doing this. Choosing the right outsourcing part...

Posted by: @rv347 In design controls, there is the DID and DSD documents. DID is design input and gives a broad description of the product (ex, "red knob"), whereas the DSD is design specification an...

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 their Development process of a Device. That being s...

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 where I will be directly in touch with the subjects ...

Having interacted with an uncle who has a degree in Biochemistry and MSc in Environmental Change and currently a Clinical Research Associate (CRA), I came to realize that not necessary will you requir...

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 a clinical trial is to see how well the device or ...

Emotional Intelligence (El) is defined as a type of social competence involving the ability to monitor one's own and others' emotions, to discriminate among them, and to use the information to guide o...

A Mission Statement defines the company’s business, its objectives and its approach to reach those objectives. A Vision Statement describes the desired future position of the company. The Mission and ...

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 making some research I found out one way or the other ...