Document control is an important method that refines the document management system. Document control reduces documentation error and ensures that the data is searchable, information is secured and documents are consistent. Depending on the company and the industry, live documents…   Read more»

It is very important that the medical devices actually do what it says it will do. This is one of the requirement in the medical device amendments of 1976 that the medical device must be safe, effective and labeled properly….   Read more»

There is a list of drugs on FDA website that have been recalled to protect public health from defective or potential harmful product. Some on the products included on the list are: Nasal Products, Baby oral gels, Homeopathic medicines, hydrochlorothiazide…   Read more»

The FDA has to be very strict to protect public health by regulations to oversee food, drugs, cosmetics and medical devices. It is true that lenient FDA regulations could increase innovation in technologies to create improved drugs and medical devices…   Read more»

Scientist know that there’s an ethical concern with animal testing and they have widely accepted the three Rs ethical principal for Replacement, Reduction and Refinement. Reduction: reducing the number of animals in experiment. Strategy that will result in fewer number…   Read more»

As mentioned before, biocompatibility testing must be performed in accordance to ISO 10993 and other FDA relevant standards. The type of testing depends on the type of device: surface, external or implant device. The biocompatibility testing will also depend on…   Read more»

It is unethical to perform animal testing however that is the optimum way as test subject to gain knowledge about potential human treatments. Animal study and experimentation can be very useful for advancing medical science. One should learn but keep…   Read more»

I have never heard of multiple project managers for the same project. There can only be one project manager per project. There are department managers involved in multiple projects or one project manager involved in multiple projects. The way a…   Read more»

The work breakdown structure represents all products and project work. It shows the total work from lowest levels to the highest levels so that nothing is left out and no extra work is completed. The WBS elaborates the work required…   Read more»

Project manager faces many challenges in medical device industry compared to project manager involved in construction of a school or skyscraper. Project manager in medical device industry faces increased clinical and regulatory standards that are being FDA regulated. Project manager…   Read more»

I think all phases of project management are very crucial for the project. Each project has to go through all 5 phases successfully to have an ideal outcome. If I was to rate the phases based on the importance and…   Read more»

I think MS would be the most optimum option for anyone’s career track. But as far as the education or the number of degrees are concerned, the more the merrier. I haven’t seen a single person with PhD who does…   Read more»

True, to some extent. When get out in the industry you will meet people with both experts of all trades and masters of one trade. People who are expert in their own field or people who have a lot of…   Read more»

I believe there should be 50:50 ratio of practical and academic courses throughout the degree program. You can read as much as you want about running an instrument but until you actually run it, you’re not proficient enough. You could…   Read more»