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 ...

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...

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...

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 fix...

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...

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 b...

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 ...

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 a...

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 o...

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.”...

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...

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 aft...

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 follow...

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...

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...