Design Verification: The Testing Phase
Part three of the design verification series discusses in detail the steps that should be taken during testing.
Tag Archives: testing
Design Verification: Process Considerations Before Testing
Prior to design verification of packaged products, consider the following process-related elements.
Design Verification: Ensure Product Protection throughout the Supply Chain
This three-part series explains how an all-encompassing testing approach will improve product reliability and secure your bottom line.
Will Your IFU Meet Usability Requirements?
Well-written and usable instructions are critical for all users.
Biological Evaluation of Medical Devices
The biological safety of a device is established for both short-term (acute) and longtime (chronic) safety risks to patients and device users. Medical device manufacturers must investigate their devices thoroughly to meet these expectations to receive approval to market their devices.
The biological safety of a device is established for both short-term (acute) and longtime (chronic) safety risks to patients and device users. Medical device manufacturers must investigate their devices thoroughly to meet these expectations to receive approval to market their devices.
How Good is Good Enough? The Importance of Medical Device Performance Specifications
Telling the parent their child has a temperature of 38.674 °C may be an impressive engineering feat, but the last two digits have no real value and any time spent in development getting there was misspent.
Telling the parent their child has a temperature of 38.674 °C may be an impressive engineering feat, but the last two digits have no real value and any time spent in development getting there was misspent.
Controlling Costs in Medical Device Development
Dozens of factors contribute to the cost of developing a medical device and every project is different. The rigor required to meet standards in the medical industry plays a huge part, but based on my experience in medical device development, several other issues often influence a project’s bottom line.
Dozens of factors contribute to the cost of developing a medical device and every project is different. The rigor required to meet standards in the medical industry plays a huge part, but based on my experience in medical device development, several other issues often influence a project’s bottom line.
Four Ways Risk Analysis and Verification Testing Can Help Prevent Recalls
When two highly respected companies like Abbott and Johnson & Johnson get caught up in recalls, we are reminded that thorough verification and validation are fundamental to successful medical device development.
When two highly respected companies like Abbott and Johnson & Johnson get caught up in recalls, we are reminded that thorough verification and validation are fundamental to successful medical device development.
