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MethodSense, Inc.
35 followers -
delivering breakthrough within the life sciences
delivering breakthrough within the life sciences

35 followers
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If you are planning to bring a product to market in the US this year, know that the #FDA 2018 MDUFA fees will be enforced soon. Some of the fees have gone up substantially, making certification as a small business very attractive. Read more to see how your #medicaldevice company might be affected. http://ow.ly/1WV330fsQrn
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What does it mean that #FDA has streamlined their process for recognizing consensus standards for #medicaldevices? Learn here => http://ow.ly/U4ay30eL3Iy
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MethodSense's senior #FDA #regulatory strategist named female CEO of the year. Check out her success story: http://ow.ly/C7II30drDLk
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FDA is creating a Digital Health Unit as a response to requirements of MDUFA and the 21st Century Cures Act. FDA has hopes this unit will streamline the regulatory approval process for devices utilizing software technologies, especially as it relates to monitoring and implementing the use of real world data.

#FDA #MedicalDevices #DigitalHealth
http://ow.ly/ySMx30cpcZF
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FDA envisions digital health unit will monitor & implement use of real world evidence to support regulatory process http://ow.ly/otAz30cpaeW
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Find out 10 things you need to know about #HumanFactors for your #MedicalDevice to satisfy #regulatory requirements http://ow.ly/zf3d30aBFSC
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Learn how @US_FDA is approaching cybersecurity to minimize the potential threat of medical device hacking. http://ow.ly/nagY309dfjL
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The 21st Century #CuresAct will create new #FDA regulations and revised requirements for #medicaldevice companies. Here is an overview of sections that may impact your product commercialization. http://ow.ly/FHus3078iyx
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