For a company, an expert or consultant helps reduce the chance of the device being rejected. They provide support for businesses since medical devices are heavily regulated and it’s a long process to have the device on the market. A…   Read more»

The biggest difference between the two is that an oral agreement is harder to prove for its existence and must be proved by memory or other evidence since it is not written down. This can create error and mischief and…   Read more»

Even though this is an awkward situation, it isn’t too restricting because this is a business dinner after all. Bringing a spouse to the business dinner is unnecessary, and if it does happen, then the physician should be in charge…   Read more»

In my opinion, the best organizational structure is the functional structure Because: Employees are grouped by their knowledge in each area and this allows them to achieve high performance, having fixed roles and responsibilities which create less complications.There is only…   Read more»

I would choose a functional organizational structure because the employees are grouped by their area of knowledge and there is one manager in charge. The project will have a team with knowledge in all areas and that way, it is…   Read more»

A successful project team should be goal oriented and the team members should have clearly defined roles. The team members should be open and clear when it comes to communication. A team should have balanced participation in order to have…   Read more»

I agree with the issues you listed above and there are many ways that risk management can go wrong. One of the ways could be reckless risk taking and it happens when the team is not taking sufficient risk oversight…   Read more»

The risk management plan consists of scope, responsibilities/authority, review reqs and criteria, risk verification, data collection and review (production and post-production).  The first 3 clauses are introductory and requirement clauses. clause 4: intended use and foreseeable hazards, estimated risk for each hazardous situation clause 5: evalua…[Read more]

Other benefits of PMS is to monitor a device for its safety, quality and effectiveness throughout its entire lifetime. This gathers data about the device and helps in further research and prevention of certain risks in the future. This gives…   Read more»

Verification is important for a few reasons: According to the FDA, “Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.” So, Verification basically confirms whether the design outputs meet the design inputs. In order…   Read more»

Some ways to make validation pitfalls is to miss parts of the process, skip testing, excluding the packaging and labeling. To make Validation right, Your design validation process must include initial production units meaning to have the device built in…   Read more»

For trial periods, drugs are conducted in four phases (I,II,II and IV). The first three trials test for safety, effectiveness, dosage, and side effects, while phase IV is a continuation in testing after the FDA approves the drug. For devices,…   Read more»

Disorganization and lack of planning and distributing of tasks can tear the design control system down. The nine steps of design control need to be implemented per code. When the process is not followed completely or specifically, it can cause…   Read more»

To make this simple, design control makes sure that there’s a plan set by the company or manufacturer that has to be implemented and makes sure all requirements are met during development. By doing so, design control protects patients from…   Read more»

Meeting minutes are crucial for assigning tasks and for each person to know what their task is if it is unclear. Also, meeting minutes give information on deadlines and what actions should be taken at each step of the way….   Read more»

Having a clinical background isn’t necessary as long as the role doesn’t deal with direct patient interaction. So depending on the role that the person is going for, the preference of a clinical background should then be determined. Having a…   Read more»

If a company invests in developing a new drug/device, then they should follow all the regulations to have an effective product. Clinical trials aid in the success of every drug or device in the market. Anything that humans will use…   Read more»

The FDA requires that any device or drug made and will be used to treat humans, should go through a clinical study/trials. Even if these drugs or devices do not improve the overall wellbeing of humans, we still need them…   Read more»

I have noticed that technological companies use the color blue such as Samsung, Dell, Intel, HP, ATT, and GE. Also, car manufacturers such as Ford, Volkswagen, Subaru, BMW, Volvo and many others incorporated blue in their logos to represent Strength,…   Read more»

Coca-Cola will always be one of my favorite commercials because it just makes me crave it every single time. The way they make it look and sound refreshing just makes it impossible to resist. But my most favorite of all…   Read more»