Roberta Goode, president & CEO of Goode Compliance International, weighs in on the latest challenges medical device manufacturers are facing in risk management at the MedTech Intelligence HHE, Risk Assessment, & Recalls Conference in Washington, DC.
Stringent REACH Standards Make Devices Safer in European Union
REACH, which stands for the Regulation, Evaluation, Authorization and Restriction of Chemicals, is a standard that was established by the European Union (EU) in 2007 but does not go into effect until 2018. Simply put, REACH immediately seeks to “limit or prohibit the use of toxic substances in products.” According to an article written by…
When a product recall occurs, typically there are complaints that can be traced back to trending issues with the specific device. During the process of assessing whether a correction or removal must take place, a company should be conducting a health hazard evaluation (HHE) to determine whether a violation has occurred. Several considerations come into…
Trading the potential health risk to a few patients versus the collective good of all patients is never acceptable. Even the experts are voicing concerns over the effectiveness of duodenoscope reprocessing.
FDA Transparency at Heart of Device Risk and Recall Discussion
The last decade has brought more interaction between the device industry and FDA related to conducting health hazard evaluations, but companies continue to face obstacles.
Changes to ISO 13485: What to Expect
A summary of the new and revised changes in ISO 13485, the second Draft International Standard (DIS2), which is planned for release this fall.
FDA Files Consent Decree Against Medtronic and CEO Omar Ishrak
Medtronic repeatedly fails to correct manufacturing violations related to its Synchromed II Implantable Infusion Pump Systems.
Build the Right Medical Device Recall Team
From ensuring patient safety to protecting a company’s reputation, the product recall process starts with putting together the right team of qualified individuals.
Who’s Liable for 3-D Printed Medical Devices?
As additive manufacturing comes to the forefront as a disruptive technology, industry continues to speculate about how liability will be shared.
Clinical Data from OUS Studies Get Guidance From FDA
The agency has released a draft guidance outlining its policy for accepting data from foreign clinical studies.
