Last seen: Nov 15, 2025
Risk management can be applied to supply chain efforts, considering that supply chain disruptions are usual in manufacturing at any time. The likeliho...
FMEA is a recommended tool for identifying potential failures early in the development phase, as well as their effects and the recommended actions to ...
Certain risks in medical device development can be mitigated but not eliminated. After the risk management plan is executed, the risk management team ...
Yes, a smaller startup can benefit from efficiently using design controls. The advantage can start as early as the design planning and scope managemen...
Design transfer and process validation are closely related processes that require careful management from the right personnel. The design transfer mus...
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. T...
The responsible persons have to research and collect data on user needs. They have to understand the user’s procedures and identify the risks & ef...
Medical device companies conduct internal audits to ensure compliance with regulations or standards. It is a great way to identify nonconformities bef...
Medical device development takes several years to complete, and drug development can take over a decade to complete. The clinical trial process has be...
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 ...
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 noceb...
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 ...
Yes, storytelling can help people understand medical devices better. The importance of clear and clever communication is found in sales as well. Hospi...
A company with a motivating mission statement and a vision that encompasses a bigger or more inspiring goal can effectively distinguish itself from co...