中国国际医疗器械设计与制造技术展览会(Medtec China)2018

Dedicated to design & manufacturing for medical device

1-3 September 2021 | SWEECC H2&H4

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Policies & Regulations

2020.06.05
A Few New Challenges with EU MDR

Experts speaking at MD&M West offered strategies for preparing for the European Union's Medical Device Regulation.



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2020.05.15
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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2020.04.20
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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2020.03.27
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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2020.01.15
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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2019.11.01
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.



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2019.08.21
Avoid These Headaches During Regulatory Submissions
Here are some tips on how to avoid deficiencies during final submissions, particularly those involving biocompatibility data.



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2019.08.01
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.



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2019.07.30
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.



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