Even though validation occurs later in the design controls process, it is based on the user needs, which are determined at the start of the process. Therefore, it would be beneficial to consider the r...

The responsible persons have to research and collect data on user needs. They have to understand the user’s procedures and identify the risks & effects of the product. External factors like indivi...

Medical device companies conduct internal audits to ensure compliance with regulations or standards. It is a great way to identify nonconformities before they become greater risks or to find ways for ...

Medical device development takes several years to complete, and drug development can take over a decade to complete. The clinical trial process has become more complex and expensive, as mentioned. Cha...

For the protection of human research subjects, regardless of the type of research, there is 45 CFR 46, which pertains to the Department of Health and Human Services. This regulation was also adopted b...

Including as many factors as possible into a clinical study to support or even improve a treatment is beneficial for the study. Both placebo and nocebo effects are helpful to understand chronic and me...

Two companies, Kimberly-Clark and Halyard Health, were found guilty of fraud eight years ago for the medical gowns they sold. The gowns were marketed for disease protection and claimed they met AAMI l...

Yes, storytelling can help people understand medical devices better. The importance of clear and clever communication is found in sales as well. Hospitals depend on purchasing departments to acquire m...

A company with a motivating mission statement and a vision that encompasses a bigger or more inspiring goal can effectively distinguish itself from competitors. A unique or modern purpose can secure s...

My previous response was intended for your other discussion on public versus private companies, which I added there. However, I want to add to this discussion about cash flow versus profit. Understand...

The medical device industry is diverse and compromises of both public and private companies. Privately owned companies benefit from reasons that you mentioned such as faster and more flexible decision...

The medical device industry is diverse and compromises of both public and private companies. Privately owned companies benefit from reasons that you mentioned such as faster and more flexible decision...

Evaluating financial ratios can determine if a company is capable of investing for returns that come later. A balance between short term financial goals versus long term investment can depend on the p...

Challenges during auditing can appear in the investigator’s audit report especially when they are QMS deficiencies. Negar and Natalie provided examples of frequent problems that can arise. As a result...