For one I would say both a patent and an NDA are needed to sign and secure your ideas and invention in a contract. NDA is simply a contract between two people. While Patent is a federal document proving ownership of…   Read more»

I haven’t been in any situation where I have to sign a Non Compete Agreement but from what I have read and what people went through, it something you need to be well educated on and get a legal person…   Read more»

This course in generally as been an eye opener to the Medical Device world. This explain in details all you need to know about the industry and how each roles overlap each other. I am excited I took this course,…   Read more»

As we begin our final project, it gradually refines you and shows you how the real industry is. This is more like a preparation of what to expect out there. And the organization type Dr. Simon went with seems more…   Read more»

Every organization is different and no organizational structure is perfect, but one of the above types of organizational structure may be best for a medical device company depend on the size of the company and what growth the foresee to…   Read more»

Though not current working in a medical device company, but I would classify my organization as more of a functional type organization where by each department has a functional head of that department. And as stated in the course material…   Read more»

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 patients and also to the operator, other persons, equipment…   Read more»

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 when making Risk-Benefit determination in Medical…   Read more»

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. The…   Read more»

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 mandated so that medical device companies can…   Read more»

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 Human factor study is needed…   Read more»

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 said above is a major requirement and guide to a…   Read more»

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 partner or company can pose a challenge unless…   Read more»

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 and gives a very specific description(ex,…   Read more»

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 said, they will definitely have to look into…   Read more»

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 and involved…   Read more»

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 require to have a clinical background or directly…   Read more»

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 drugs performs…   Read more»

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 one’s thinking and actions. This involves a set…   Read more»

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 vision statement are important because this helps establish a framework…   Read more»