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…
While support services are important, manufacturers must be aware of both state and Federal regulations, as there can be conflicts and differences in interpretations.
While support services are important, manufacturers must be aware of both state and Federal regulations, as there can be conflicts and differences in interpretations.
If you work in the device industry in the United States and introduce FDA approved/cleared product into commerce in the United States, then it is incumbent upon the device establishment to play by FDA’s rules. Remember, if you are playing in FDA’s sandbox, then you must play by FDA’s rules.
Facilitating a RI department can quickly become an expensive proposition. Adding a vision system, mechanical inspection tools, a reasonably-sized surface plate, and hiring/training competent mechanical inspectors is not cheap. However, device establishments can mitigate some of the costs by implementing some pretty basic inspection concepts.
Canadian medical device market regulator Health Canada will begin requiring all reprocessed single-use medical devices to comply with Canadian Medical Device Regulations (CMDR) by September 1, 2015.
Canadian medical device market regulator Health Canada will begin requiring all reprocessed single-use medical devices to comply with Canadian Medical Device Regulations (CMDR) by September 1, 2015.
Once device establishments figure out the compliance piece, life in a regulated environment becomes much more enjoyable.
The legislated FDA Unique Device Identification regulation is a single device identification system that is invariable, absolute, standardized, and globally reconciled. All medical device manufacturers will be required to comply with the new UDI approach. Here’s some information for you to get started.
The legislated FDA Unique Device Identification regulation is a single device identification system that is invariable, absolute, standardized, and globally reconciled. All medical device manufacturers will be required to comply with the new UDI approach. Here’s some information for you to get started.
