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January 14, 2015
CPSC Fines Continue to Increase Yearly – Compliance is Key
The trend of increasing CPSC enforcement is expected to continue in 2015, with the agency taking a tough stance on companies failing to report product safety issues.Read More
January 7, 2015
Enhance Medical Device Cybersecurity to Help Prevent Product Recalls
As stories of medical device cybersecurity flaws surface, manufacturers should expect increasing FDA regulations and guidelines in the near future. Get expert tips on preventing software related medical device recalls and current FDA guidelines here.Read More
November 20, 2014
New Q3 Recall Index Looks at Why It’s Not all Blue Skies For Medical Device Recalls
In the third quarter of 2014, FDA Enforcement Reports documented 297 medical device recalls – an increase of 8% from the prior quarter. While the industry has not witnessed the dramatic fluctuation in recalls experienced by auto manufacturers or other sectors, there are a variety of factors beyond the industry’s consistent recall volume that contribute to an uncertain position.Read More