Preparing for the EU Medical Device Regulation

Despite a delay to the EU MDR, there are many changes for medical device manufacturers to put in motion now. Can freelance scientists help?

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Artificial Intelligence and Machine Learning-Based Medical Devices: A Products Liability Perspective

How will products liability law be applied to AI?

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3D Printing of PPE and Other Medical Devices

Consider the trade-offs of using 3D printing to address current supply demands of personal protective equipment.

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Proposal to Postpone EU Medical Device Regulation Underway

A delay of one year could allow authorities and industry to focus instead on urgent responses needed to address the COVID-19 pandemic.

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Design Controls, Deconstructed

Here’s what you need to know about design controls and the critical role they play in your regulatory journey.

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FDA warns of device shortages again due to sterilization plant closures

The FDA today warned of “years of spot or nationwide shortages” of a number of surgical kits and implantable medical devices due to the closure of two medtech sterilization plants that use ethylene oxide (EO) and efforts in Georgia to close a third.

Avoid These Headaches During Regulatory Submissions

Here are some tips on how to avoid deficiencies during final submissions, particularly those involving biocompatibility data.

New Approval Helps Implanting Propel Mini a Little Bit Easier

The Menlo Park, CA-based company said it has received a nod from FDA for the Straight Delivery System for use to place its Propel Mini Steroid implant.

Medtronic Looks to Expand Reach of Artificial Pancreas with New Submission

The Dublin-based company filed a PMA submission to FDA requesting for non-adjunctive labeling for the Guardian Sensor 3, as part of the MiniMed 670G system.

The deadline for ISO 13485:2016 certification is . . . now!

Are your critical suppliers in compliance?