Most Popular Stories of 2015
5: How New FDA Expectations for Human Factors Affect Process and Medical Device Submissions
FDA’s perspective on human factors and usability engineering has evolved.
4: The Integration of Complaint Handling and Risk Management
A review of the important aspects of risk management and post-market surveillance processes, and how to resolve common concerns.
3: Medtronic’s European Research Center Focuses on Innovation for Survival
The company’s Bakken Research Centre in the Netherlands is centrally located for technology development and collaboration with physicians.
2: Changes to ISO 13485: What to Expect
A summary of the new and revised changes in ISO 13485, the second Draft International Standard (DIS2).
1: Heigh-Ho, Heigh-Ho, It’s Off to Jail You Go
Charlie Chi, former CEO of OtisMed Corp, is sentenced to prison for shipping adulterated medical devices into interstate commerce.
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The acquisition brings MAXIS’ expertise in pre-clinical engineering, design validation and verification, regulatory affairs, field clinical services, and trial management to Avania’s contract research and MedTech development capabilities.
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The acquisition expands Veranex’s European footprint as well as the scale and scope of its clinical studies capabilities.
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Bringing design and quality assurance processes together earlier in the device development process can reduce costs and nonconformances, while improving outcomes.
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Pulvinar Neuro has received a $3 million dollar NIH grant to further its research on noninvasive transcranial alternating current stimulation for the treatment of depression.
