Oasys Occipito-Cervico-Thoracic System by Stryker Faces Class I Recall
Aug 29, 2013
Stryker initiated a recall of its Oasys Occipito-Cervico-Thoracic System. FDA regulators assigned the recall Class I status, indicating a serious risk of patient injury or death...
How to Deal with a Medical Device Recall: An Expert Weighs In
Aug 28, 2013
Medical device recalls ticked up in the second quarter of 2013. Image from Stericycle ExpertRECALL. Medical device recalls at a five-quarter high and dealing with them has become increasingly complex as a result of globalization. "The number of...
New Lead Alternatives Can Cause New Problems
Aug 20, 2013
New tin-based solder alloys are poised to rise dramatically in electronics manufacturing as OEMs modify their supply chain and manufacturing efforts to comply with the Restriction of Hazardous Substances (RoHS) directive imposed by European...
Compliance Testing Standards: ISO/IEC 17025
Aug 14, 2013
 ISO 17025 is critical for medical devices, and manufacturers must ensure testing suppliers are accredited and compliant.
Improving Business Results Through Value Engineering
Aug 07, 2013
Medical device manufacturers are constantly challenged to drive down product costs for a variety of reasons—lower cost targets aligned with emerging markets, competitive need to improve product margins, or a desire to extend the life of legacy...
Acoustic Screening and Analysis of PEMs for Medical Applications
Aug 06, 2013
 Ultrasound can be used as a tool to test the reliability of medical electronics components. 
GE Recalls Over 20 Scanner Models after Patient Crushed to Death
Jul 30, 2013
Following the death of a patient last month, GE Healthcare issued a recall for several of its nuclear imaging scanners. FDA regulators issued Class I recall status for all the affected models. (Note: For a breakdown of other recent Class I recalls...
How to Ensure Battery Safety and Security in Wireless Medical Devices
Jul 03, 2013
As today's medical device manufacturers seek to power next-generation wireless devices, they are faced with two integral design and engineering challenges: safety and security.Real-time assurance reporting and other advanced features, such as data...
Adverse Medical Device Events Involve Children Most, Study Shows
Jun 07, 2013
 A study released today by the Cincinnati Children’s Hospital Medical Center and published in the Journal of Hospital Medicine has found that the very devices that are helping children with complex conditions are also creating adverse medical...
Field Users Say New Plug Discharge Test Will Take More Time than Expected
May 30, 2013
As you may or may not already be aware, the new Plug Discharge Test has appeared, or will appear in the next edition of IEC 61010, IEC 60065, IEC 60335 and IEC 60950. The purpose of the test is to make sure that the energy contained in any primary...
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