A New Look at Medical Device Reprocessing Validations
A New Look at Medical Device Reprocessing Validations
Aug 12, 2014
Medical device designers must ensure that their non-patient-contacting medical equipment surfaces can be cleaned and disinfected.  
Complaint File Management for Medical Device Manufacturers
Complaint File Management for Medical Device Manufacturers
Aug 11, 2014
A well-written procedure documenting the complaint management process, including the creation of a complaint form, is required by the QSR. 
What Do Device Makers Look for in Clinical Outsourcing Partners?
Aug 05, 2014
 Major medical device makers are expecting more clinical trials as they expand into emerging markets and have common strategies and expectations around the contract research organizations [CROs] they work with.  
ATS Labs Acquires MicroTest Labs
Jul 14, 2014
ATS Labs of Eagan, MN, has bought MicroTest Labs of Agawam, MA, as part of its efforts to expand its microbiology and chemistry laboratory services, which are focused on the medical device and biopharmaceutical industries...
Does Your Quality Management System Still Rely on Tools from the 1980s?
Does Your Quality Management System Still Rely on Tools from the 1980s?
May 14, 2014
If 20th-century programs such as Microsoft Word and Excel still form the backbone of your QMS, it might be time for a change.  
15 Highest-Paid MedTech CEOs In the U.S. (#11)
Apr 21, 2014
Kieran T. Gallahue, Chairman and CEO, CareFusion [Photo Courtesy of CareFusion] Gallague made $9.6 million in 2013, a drop of 3.4% from the previous year.  
How the New FDA Biocompatibility Testing Guidance Could Affect You (Part 3)
Mar 18, 2014
The new draft guidance document is the most expansive presentation of testing standards for the medical device industry in more than 18 years.
How the New FDA Biocompatibility Testing Guidance Could Affect You (Part 2)
Mar 18, 2014
The new draft guidance document is the most expansive presentation of testing standards for the medical device industry in more than 18 years.
How the New FDA Biocompatibility Testing Guidance Could Affect You
Mar 18, 2014
The new draft guidance document is the most expansive presentation of testing standards for the medical device industry in more than 18 years.
A New Biocompatibility Test: Zebrafish Embryo Toxicity Testing
Mar 07, 2014
Biocompatibility testing is a necessary part of any medical device validation process. It is governed by FDA’s ISO 10993 guidance document, a seemingly rigid statement that provides a general matrix dictating that some products require additional...
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