ISO 14971 is the primary ISO rule that regulates risk management for medical equipment. ISO 14971 is a worldwide standard that offers a framework for controlling the risks connected to medical devices at every stage of their life cycle, from…   Read more»

An example of avoiding risk is when a specific substance used in the urinary catheter was found to have the potential to cause allergic reactions in certain patients . The company chooses to modify the urinary catheter using a different…   Read more»

Risk assessments are required for medical devices. The regulatory framework for medical devices must include risk assessment as a fundamental element in order to guarantee the long term efficacy and safety of these devices. Risk identification, which begins with the…   Read more»

Like most of the comments, I believe that companies are taking their corporate responsibility very seriously. Companies are now expected to conduct business ethically, addressing matters like honesty, integrity, and transparency in their dealings with patients and healthcare providers. Furthermore,…   Read more»

To guarantee an efficient project management procedure, a number of elements should be taken into account when arranging tasks and generating a Gantt chart. As most have indicated, timeliness is a key consideration. Another crucial piece of information that has…   Read more»

Interim design review meetings are frequently brought about by the requirement to be flexible and adaptable to changing conditions as the product is being developed. An interim design review meeting may be scheduled for a variety of reasons by a…   Read more»

I believe that staff skill levels, project complexity, and company size have the biggest effects on design control roles. More specialized positions may exist in larger organizations, enabling engineers to concentrate on particular facets of design controls. Employees can have…   Read more»

When developing test procedures and protocols, some important things to take into account could be Standards and Regulations Compliance aspects, which mean making sure our testing procedures adhere to relevant legal requirements.Additionally, the tests that are required should be determined…   Read more»

One of the functional requirements for an artificial cervical disc is that it should permit the cervical spine to move in a manner that is comparable to that of a healthy natural disc, including flexion, extension, lateral bending, and rotation.A…   Read more»

I think investigator and study coordinator are two roles within clinical research that suit me best. I have experience working with doctors and patients. I have been working in my family’s private medical clinic for several years. My responsibility was…   Read more»

First, I disagree with your claim that “No one has ever claimed that their illness was cured by any pharmaceutical drug.” As a simpler example we can mention the first use of penicillin. Before antibiotics were invented, people died from…   Read more»

I think that money is not an efficient method to attract many people to be part of a clinical trial because in these situations it would take a lot of money to pay all the participants in the clinical trial….   Read more»

  The way products are promoted has been significantly altered by the internet. Prior until now, clients were reached through meetings, exhibitions, newspaper ads, and television advertising. Nowadays, online and viral advertising are among the main methods of product promotion….   Read more»

The importance of building trust as a sales representative with a customer is very important.This is a quality that every sales representative working in the medical device field should have.Sales representatives usually become friends with doctors because they sell products…   Read more»

In my opinion this question has several answers as the internet has changed the way of doing marketing and marketing in many aspects. The biggest change the internet has brought is the ability to advertise and sell a product online…   Read more»

A C-corp is an example of a large company with thousands of employees and hundreds of shareholders, such as Amazon, Google, Apple, etc. S-Corp, on the other hand, are smaller businesses with fewer stockholders and employees. XYZ Inc. is a…   Read more»

  I founded a startup with a friend, and we registered our business as a C-corp in the state of Delaware. Compared to other US states, Delaware has exceptionally favorable tax regulations and little prerequisites for corporation formation.  My friend…   Read more»

I believe that the response to this question relies on the level of experience and years of employment a person may have. By this, I mean that a recent graduate can consent to begin working for any kind of business…   Read more»

I think that deciding to give up on a project should happen during the initiating and planning phases. This way we will save the money and the effort we might put in the execution phase. For example, one case where…   Read more»