Risk management can be applied to supply chain efforts, considering that supply chain disruptions are usual in manufacturing at any time. The likelihood of supply chain disruption is higher, and the s...

FMEA is a recommended tool for identifying potential failures early in the development phase, as well as their effects and the recommended actions to be taken. Global organizations such as the Six Sig...

Certain risks in medical device development can be mitigated but not eliminated. After the risk management plan is executed, the risk management team must measure the effectiveness of their plan. Resi...

Yes, a smaller startup can benefit from efficiently using design controls. The advantage can start as early as the design planning and scope management phases. A smaller startup may be more likely to ...

Successful process validation is intended to prevent product recalls, as there is evidence that the manufacturing process can be replicated while meeting all the requirements. For an original equipmen...

Design transfer and process validation are closely related processes that require careful management from the right personnel. The design transfer must be completed so that the manufacturing stage can...

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...