Matrix organisations are where the employees have more than one boss and work on multiple teams. This leads to multiple streams of goals that complete for time and attention. The other conflicts are t...

I prefer to take middle level management as they are accountable to the top management for their department function and responsibilities. They execute organizational plans in conformance with the com...

Choosing a project team is one of the important aspects in setting up the right path towards the goal. The selection of team members is by choosing the right person having the required skills to do th...

The factors contributing to risk values include occurrence, severity of the failure and noticeability as given in Dr. Simon’s lecture. The severity is measured based on severe, significant and minor w...

A risk benefit analysis must be considered carefully in developing devices and improving existing devices/products. It is the comparison between risks of a situation along with its benefits. Analyzing...

Risk identification is the first step in risk management process. To carry out risk analysis, we have to list the possible threats that we encounter and then estimate the likelihood that these threats...

A validation is not required if the product changes did not affect the user interface or clinical trial is not needed. It is necessary only for checking product specifications, interface standards and...

Design verification and validation are main elements in design controls. Design verification is where the design inputs are verified with its output and all outputs must be verified. Whereas design va...

Insufficient design controls arise when the procedures are not followed properly or the standard procedures aren’t written. Insufficient design controls lead to the failure of the whole product. So th...

This is one of the most important part of the medical device project. The design development plan describes all the design controls, project layout and project scope. The plan describes all the team m...

Design inputs are starting point for product design. The requirement which form the design input establish a basis for performing subsequent design tasks and validating the design. The development of ...

Design controls are mandated by FDA in the year 1996 and defined in FDR 21 CFR 820.30. It monitors the steps in designing and creating the medical device. It demonstrate the medical devices are safe, ...

In a single blind study, the experimenters are aware of which subjects are receiving the treatment but the participants are not aware. This type of study is useful from preventing participants from al...

On my suggestion, I would prefer to be a Clinical investigator in closely investigating the subject’s health data. This role is where the investigator has to gather the subject’s medical history befor...

Clinical trials are risky but it is necessary regardless of how many preclinical trials are performed. Testing a subject (individual) is not that good but however helping for the mass of humankind wou...