Profile

Meenakshi Verma

Contact Details

India

Contributions

1 to 5 of 50+ total

RE: Japan PMD act- recent update

Posted By Meenakshi Verma 25-Dec-2020 13:52
Found In Egroup: Regulatory Open Forum \ view thread
Hello Taly, Not sure if this is the most recent version, however, please check the below link for the English translation of the Act. http://www.japaneselawtranslation.go.jp/law/detail/?printID=&re=02&id=3213&lvm=01&vm=02 Thanks, Meenakshi ------------------------------ Meenakshi ...

RE: UDI-PI for standalone software not sold as packaged

Posted By Meenakshi Verma 02-Sep-2020 11:46
Found In Egroup: Regulatory Open Forum \ view thread
Hi, As per FDA's guidance (https://www.fda.gov/media/89275/download) - All stand-alone software, whether packaged or unpackaged (e .g., software downloaded from a website), must provide its UDI through either or both of the following: (1) An easily readable plain-text statement displayed whenever ...

RE: Change of name of company impact on 510k

Posted By Meenakshi Verma 02-Sep-2020 07:53
Found In Egroup: Regulatory Open Forum \ view thread
Hi, Example on Page 64 of the FDA guidance (https://www.fda.gov/media/99812/download) provides some insight.  Important is to evaluate all the changes which may apply. ------------------------------ Meenakshi Verma Regulatory Affairs Professional - Medical Devices Ontario Canada -------- ...

RE: Harmonized Standards

Posted By Meenakshi Verma 24-Aug-2020 14:13
Found In Egroup: Chicago Chapter \ view thread
Hi Yaseer, To sell in Europe the device must undergo a conformity assessment from a MDD designated notified body (for Class IIa, IIb and III devices). QMS audit requirements will also apply. From the standards you listed above, seems like it is an active device and has a software as well. DoC to ...

RE: EU MDR PMS Requirements for Non-Medical Devices

Posted By Meenakshi Verma 01-Jul-2020 20:58
Found In Egroup: Regulatory Open Forum \ view thread
Hello George, How I see it from my lens is that the legal manufacturer (LM) can document in the technical file the products which are to be used with the device, however, not considered as a device and a rationale for that. If during the review the notified body disagree with it, the reviewer will ...