My company manufactures a blood-based infusion product that is currently undergoing its clinical phase in trials, so it is common for errors to occur along the process which are then handled under a r...

The first part of risk management, as mentioned, is to assess all the potential threats of a device by formulating a list of risks associated with its use. Each risk is then individually analyzed so ...

The major ISO for risk management is ISO 14971, which is enforced onto medical device companies as a means of preventing or mitigating the hazards associated with the devices. As mentioned in lecture...

A proper validation process should revolve around the patient by ensuring that the medical device under development meets the user's needs. An important aspect of design validation, as mentioned in l...

The clinical research company I work for carries out cell therapy in that T-cells are taken from a patient's blood, which are then amplified via additives (viral vectors), and then expanded/proliferat...

The company that I work for carries out clinical research involving the processing of auto/allogeneic cell-based products for therapeutic purposes. Each project team is required to hold meetings at t...

I have not worked with Gantt charts in industry, though I have during my senior design project in developing a neuro-prosthetic arm. The first factor to understand is to know the relationships betwee...

The design transfer process aims to translate the design of a medical device into a production procedure in which the manufactured device can fully manifest its safety and efficacy in a way that compl...

Design controls are certainly enforced throughout the development process of medical devices in the EU, the real question is whether or not they are sufficient enough to yield safe and effective medic...

An advantage to clinical testing is being able to come up with a breakthrough medical device/technique that treats many patients to unique illnesses while of course, being lucrative. A disadvantage i...

The debate as to whether or not informed-consent should remain a law or be defunct really comes down to the pros and cons. If Henrietta Lacks had the option of selecting "No" on the informed-consent ...

When analyzing the qualifications for a CRA position, the first factor that comes to mind is what type of clinical product is being put through trial? If a Class III product such as a new pacemaker o...

A vision statement is a company's envisionment of the future regarding where they hope to stand and what they hope to have accomplished while a mission statement states how its vision is going to come...

The participation aspect of marketing (the fifth "P") seems to have gained recognition over the past two decades due to the excessive tactic of "push marketing", which as explained in lecture is in de...

Emotional Intelligence (EI) is the level of intelligence one possesses when analyzing the emotional state or condition that another individual is in so that they can be engaged in a way that is benefi...