Dedicated to design & manufacturing for medical device
14-16 September 2020 | SWEECC H2&H4
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. 阅读更多
Experts speaking at MD&M West offered strategies for preparing for the European Union's Medical Device Regulation. 阅读更多
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? 阅读更多
Despite a delay to the EU MDR, there are many changes for medical device manufacturers to put in motion now. Can freelance scientists help? 阅读更多
2020.04.26 Artificial Intelligence and Machine Learning-Based Medical Devices: A Products Liability Perspective How will products liability law be applied to AI? 阅读更多
How will products liability law be applied to AI? 阅读更多
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. 阅读更多
Consider the trade-offs of using 3D printing to address current supply demands of personal protective equipment. 阅读更多
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. 阅读更多
A delay of one year could allow authorities and industry to focus instead on urgent responses needed to address the COVID-19 pandemic. 阅读更多
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. 阅读更多
Here’s what you need to know about design controls and the critical role they play in your regulatory journey. 阅读更多
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. Read More
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. Read More
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. Read More
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. Read More