Biocompatibility Testing: Are You Considering Interactions Between Packaging and Devices?
Biocompatibility Testing: Are You Considering Interactions Between Packaging and Devices?
Dec 07, 2017
MD&M Minneapolis speakers point out potential sources of extractables and leachables to consider.
DDL Expands Testing Portfolio to Support Combination Products
DDL Expands Testing Portfolio to Support Combination Products
Oct 26, 2017
Mechanical and chemical testing are needed to bring complex drug-delivery products and other combination products to market.
Avoid the Consequences of an Experiment Gone Wrong
Avoid the Consequences of an Experiment Gone Wrong
Aug 29, 2017
Linking the experimental process to the design controls defined by FDA can help ensure an effective and efficient new product development effort, as well as a competitive market advantage.
Design Verification vs. Design Validation: Right Questions or Right Answers?
Design Verification vs. Design Validation: Right Questions or Right Answers?
Aug 21, 2017
When it comes to verification and validation, medical device companies need to ensure that what they're doing actually makes sense. 
Risk of Wire Breakage Prompts Penumbra Recall
Jul 24, 2017
FDA said 155 devices on the U.S. market are included in a recall of Penumbra's 3D Revascularization device because the delivery wire could break or separate during use.Amanda PedersenPenumbra initiated a voluntary recall of its Penumbra 3D...
Did Magellan Try to Hide its Quality Control Problems?
Jul 13, 2017
Meridian Bioscience's diagnostics unit knew about its faulty blood lead test results for almost three years before FDA caught wind of the problem, the agency noted in its inspection report.Amanda PedersenAt best, Magellan Diagnostics ignored...
Hospital Disinfectants: Why You Should Reconsider Your Materials Testing Approach
Jul 05, 2017
Materials provider has developed a testing protocol for evaluating the effects of disinfectants on plastics.  ...
Some Surgical Nav Systems are Error-Prone, FDA Warns
Jun 15, 2017
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What Caused Magellan’s Lead Test Problem? FDA is Stumped
Jun 06, 2017
FDA has not been able to identify the root cause of Magellan's inaccurate lead test results, and the recall has been expanded to include two additional testing systems.Amanda PedersenFDA is conducting studies with the CDC to identify the cause of...
Harmful Chemicals in Spine Implants Prompt Zimmer Recall
Jun 01, 2017
Zimmer Biomet recalled two implantable spinal fusion stimulators after a routine cytotoxicity test indicated high levels of chemicals that could be toxic to tissues or organs.Amanda PedersenZimmer Biomet is recalling its SpF PLUS-Mini and SpF XL...
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