Design Control states that when manufacturers or suppliers develop a product subject to design controls, they shall establish and maintain the proper documentation to ensure the specified design requirements are met. It sets practices and procedures to assure that the device meets user needs, intended uses and specific requirements. Design control…[Read more]

Design input document: The purpose is to give the reader a broad general understanding of the system or component. There may be many levels of design documents. It contains the physical and performance requirements of a device that are used as basis for device design. It appropriately addresses needs of user and patient. The purpose is to give the…[Read more]

The user needs you have defined should be the primary source for your design inputs. When a team is involved, you get everyone’s experience and opinions, which will make the effort stronger. Besides user needs and the team, there are several more sources you should consider while defining design inputs: Industry standards, Regulations, Previous p…[Read more]

Clinical research are the fastest way to find effective treatments, improve standards of care, and identify methods to improve health care. Participating in clinical research is essential for the development of new medications and new treatments. Participants volunteer to gain access to new medicine, therapies, and/or medical devices before they…[Read more]

Placebo controlled experiment is a study where controlled group is given a placebo while another group is given the drug that is being tested. This way the results can be compared with the placebo group. Placebo is meant to look just like a treatment or medicine, but in reality is not. It is just a look-alike treatment. All test subjects in a…[Read more]

In a single blind experiment, the subjects don’t know if they are the experiment test group or members of the control group but the tester knows. The subjects are not told their identities in the experiment. The subject receiving the medicine would not know if they were receiving the drug or the placebo. In the double blind experiment, both the…[Read more]

One of the most common ways to market a new product is through medical device representatives. Medical device representative helps both surgeons and patients by providing useful information and training. They help ensure that the surgeon use the device correctly, thereby improving the patents health and safety. This way the medical device…[Read more]

According to identifying and evaluating business strategies there are about 17 gran strategies that describe program of action and resource allocations. These strategies include concentration, market development, product development, innovation, horizontal integration, vertical integration, concentric diversification, Conglomerate diversification,…[Read more]

The colors that a company chooses to represent their brand can affect the feelings, mood and behavior of their target consumer and influence whether or not a brand will become part of their selection set. The color branding used for marketing usually depends on the industry or the type of product. Different shades of green are being used to evoke…[Read more]

As mentioned by ih37, the biggest difference between a public company and private company is that you could buy shares of the public company and the company is required to file quarterly earnings reports with Securities and Exchange Commission. This gives public companies advantage to raise capital to expand the business by selling stocks and…[Read more]

I would consider someone for business partnership if I am able to trust them and their ability to handle the business. I will consider them if he/she shares the same professional values, ideas and goals and how they handle everyday life and business decisions. If i haven’t worked with them previously, I would test the partnership by tackling a s…[Read more]

I would like to be part of General Partnership Corporation where 2 or more people are involved in starting a business and contributing money, skills and labor towards the business. General partnership is the most common type of partnership. The liabilities, contributions, and responsibilities of the partners are usually equal unless and until…[Read more]

Quality Control controls the quality of the product to ensure customer requirements and needs are meet and Quality Assurance assures that quality requirements will be meet based on customers, FDA, regulations, certifiers and 3rd parties. QA and QC works together and establish quality guidelines and objectives that act as guidance for an…[Read more]

I think one of the way to have better relationship within the departments is to improve communication and ways of communication. Departments should realize that they are working for the same company towards a common goal. Department managers should know that helpfulness goes both ways. Also managers should take the lead and reinforce organization…[Read more]

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 and historical records have been evolved from manual and paper…[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. The device should not kill people, it must do what it’s supposed to and the device can’t have false information. FDA tak…[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 tablets, ibuprofen, sinus relief, compounded drugs and piperacillin and tazobactam…[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 however that does not guarantee the proof of safety from extensive research and clinical trials.…[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 of animals used to obtain sufficient data.
Refinement: using experiment m…[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 the type of contact with the device and the biological effects due to the device…[Read more]