
Gain More Control over Your Supply Chain
Finding ways to better manage inventory, provide security and product integrity, and maintain continuous improvement are among the goals of logistics professionals.
Finding ways to better manage inventory, provide security and product integrity, and maintain continuous improvement are among the goals of logistics professionals.
Assessing the Manufacturing Readiness Level of your new product can help identify risks and opportunities to cut time to market.
Manufacturers that make custom devices must move beyond conventional engineering practices to an automated and collaborative engineer-to-order process.
Differing approaches to risk could hamper further growth of combination products.
The creation of the Office of Combination Products more than a decade ago may have been a big step forward, but frustrations surrounding policy-making and coordination between CDRH, CDER and CBER remain.
This year’s work plan includes several items that will impact medical device manufacturer and suppliers.
REACH, which stands for the Regulation, Evaluation, Authorization and Restriction of Chemicals, is a standard that was established by the European Union (EU) in 2007 but does not go into effect until 2018. Simply put, REACH immediately seeks to “limit or prohibit the use of toxic substances in products.” According to an article written by…
Combination products are a major growth area for life science companies and in the future, many companies have or will have combination products in their portfolio. Combination products are made of drug, device and/or biologics constituent parts. Each constituent part has its own set of regulations to which it must adhere. For example, even if…
When a product recall occurs, typically there are complaints that can be traced back to trending issues with the specific device. During the process of assessing whether a correction or removal must take place, a company should be conducting a health hazard evaluation (HHE) to determine whether a violation has occurred. Several considerations come into…
For 3D printing to thrive in the medical device space, the use of biomaterials must be expanded.