An ideal project team should have a project manager with a strong leadership. The team should possess common goals and objectives and require good communication skills. The next thing is about the technical skills that must be present with all…   Read more»

From Dr. Simon’s first week lecture, the FDA defines a medical device as an instrument, apparatus, implement, machine, contrivance, implant, invitro reagent or other related article or component part which is recognized in the National Formulatory or USP, is intended…   Read more»

This is a kind of topic that should be included in the lecture. A non complete agreement is a legal contract between the employer and employee in which the employee should not enter into a competition of the employer during…   Read more»

The main difference between oral and written agreement is that it is harder to prove the existence of an oral contract. Since it is not written down, the existence of the terms must be proved by the memory of the…   Read more»

I totally agree with @sam-doksh. Contract laws are one of the legally enforceable agreement between the parties to do something (or not to do something). They are one of the most common legal documents in both personal and business lives….   Read more»

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 the resourses shared widely across the organisations…   Read more»

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 company’s policies and the objectives of the top management. Middle managers…   Read more»

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 the job. The team…   Read more»

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 while occurrence is measured based on frequent, infrequent or occasional….   Read more»

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 is considered a human factor. A certain level of risk…   Read more»

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 would materialize. FMEA methods are implemented to…   Read more»

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 judging through end user’s perspective view. In my…   Read more»

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 validation is needed to check how well the device is…   Read more»

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 the design inputs should be given about what is asked for;…   Read more»

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 members including roles and responsibilities. This is…   Read more»

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 a solid foundation of requirements is the single most important…   Read more»

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, effective and meet the indications…   Read more»

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 altering the behavior to conform to what they…   Read more»

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 before testing on them. The investigator has to treat…   Read more»

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 would be beneficial for all. The most practical…   Read more»