Tuesday, May 10, 2011 9:44 AM
How to Feel Positive about a Biocompatibility Test Failure
By Thor Rollins, RM(NRCM)
Biocompatibility testing is common in the medical device industry, but with 24 categories under which a device could qualify, biocompatibility testing can be intimidating. The majority of biocompatibility failures are not catastrophic and can be solved without significant delays, cost or recalls. Having a plan in place will expedite that process and get the product to market in a timely manner. Always anticipate a failure and be prepared with options before they happen.
Manufacturers are aware of the myriad of tests that need to be conducted on their devices to pass regulatory requirements before they are released to the marketplace. Although, a common misconception that manufacturers have is that a test failure is catastrophic and they have to go back to square one with their product. But that isn’t always the case. Biocompatibility testing is common in the medical device industry, but with 24 categories under which a device could qualify, biocom more...
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