Soapbox

Now You’re Speaking My Language:
Modernizing Instructions for Use to Comply with MDR

By Charlie Kim, Soom

The regulation is bringing digital enablement to the forefront, requiring electronic instructions for use.

CDRH Warns of Potential Device Shortage with Shutdown of Sterigenics Facility in Illinois

By Maria Fontanazza, Editor-in-Chief

According to the FDA, more than 90% of products sterilized at the facility are medical devices.

Report: FDA Commissioner Scott Gottlieb Resigning

By MedTech Intelligence Staff

The resignation will be effective in about a month, according to reports.

Featured Quote

There’s a healthcare crisis plaguing today’s hospitals and patients, yet few seem willing to address it. Hiding in plain sight at the bedside of nearly 90% of patients within hospitals are IV pumps, and these critical devices are responsible for numerous medication errors reported to the FDA each year.

— Susan Niemeier, Ivenix

Intelligent Design Control for Medical Devices

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• Medical Device Audits, Certification & Verification
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Whitepaper - The impact of regulatory requirements on bringing medical devices to market.

There are many steps involved in the process of bringing a device to market, especially examining the regulatory environment in which medical device customers operate. Depending on your device, its indications or the presence of drug or biologic components, submissions to the U.S. FDA, EU Notified Bodies or Competent Authorities, and other regulatory bodies might be considered, but if you're using a component as a layer between other components of your medical device, or if you're using a component to adhere a device to skin, more may be expected from you by the FDA or other regulatory agency reviewers. When adhering a device to skin special attention should be given to the final, finished device composition and biocompatibility, inclusive of all component(s).

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