To add to this discussion, I think its important to note that an internal audit does not mean that it has to be performed by the company employees. For example where I work we do our own internal qual...

I think management should already have a good understanding of the resources needed to uphold their QSR. As we learned this week in lecture Management oversees the subsystems: i. Design Controls, ii. ...

In a recent article published March 26th, it was reported that the FDA is strongly considering updating its quality system requirements for medical device manufacturers to utilize the ISO updated qual...

I agree with @tme3 that the ambiguity of GMP's could actually be beneficial to a startup because it allows for a little more flexibility to create their own quality system and since each company is di...

You could monitor progress by looking at EV and SV. Earned Value-the value of the work you have completed so far. Earned Value=Percent complete*original budged cost of task Schedule Variance (SV)= EV-...

I would add to this, contingency plans. At the beginning of each project we usually have clearly defined plans with assigned responsibilities and then the inevitable happens when something unforeseen ...

My office is a little unique in which we have a lot of products that we ultimately out-license to larger device companies. We develop the products and file patents on them and in some situations the m...

We usually use passive marketing techniques where people come to us for a license and we usually have consistent sales. However in the last year in order to increase sales, we have created a catalog o...

I agree with the posts above that its important to have both business and interpersonal skills, but I believe its essential to have interpersonal skills to get deals done. Sales is all about not just ...

Over a year ago I was assigned to manage the development of a robotic device. We had a prototype and since it is now first to file, we filed a patent so we could further the development while also pit...

I personally think the planning phase is the most important phase during a project. It sets the tone for the project and as Dr. Simon mentions if you fail to plan, you plan to fail. For instance if yo...

As @cdj24 mentioned SV=EV-PV. Where EV is the percent complete* original budgeted cost of task and PV is the vale of the work you are supposed to have on a certain date. I agree as others have mention...

Just to provide another perspective, at MSK we file patents on technologies like medical devices in order to protect IP and to ultimately outlicense. Before we file a patent, we evaluate the technolog...

As most have mentioned like @asmibana and @sanam funding in a major role. I work at MSK in the Office of Technology Development so we constantly have new invention disclosures, but unless the PI has r...

The Discovery and Innovation phase as many have mentioned is the part of the life cycle that identifies customer needs, market, and competitors the "Climbing the Hill" phase where we search for ideas,...