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Shikha Malik

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United States

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1 to 5 of 50+ total

Label translations

Posted By Shikha Malik 06-Nov-2023 17:55
Found In Egroup: Regulatory Open Forum \ view thread
Hi all, I am working on an EU MDR submission for a kit consisting of more than one product. I wanted to understand if we are supposed to translate the name of each product on the label for the EU region and other countries where we are planning to ship the product. Thanks! ------------------------------ ...

MR safety on a label

Posted By Shikha Malik 30-Oct-2023 18:01
Found In Egroup: Regulatory Open Forum \ view thread
Hi all, Need some guidance on explaining the MR safety on a label for a medical device distribution per EU MDR. If a device is composed of an implantable portion (MR safe) and an accessory used to implant the device in the body (accessory is non-implantable & MR unsafe), what is the best way to ...

RE: Differences between Chinese and US/EU submissions

Posted By Shikha Malik 16-Oct-2023 16:47
Found In Egroup: Regulatory Open Forum \ view thread
Hi Ryan, This is an interesting question and I suppose China has type testing requirements in addition to the verification and validation testing to suffice the NMPA criteria. I would love to get someone else's opinion on this as well. Thanks! ------------------------------ Shikha Malik Sr. ...

EU MDR Patient Implant Card requirement for Implantable Accessories.

Posted By Shikha Malik 27-Sep-2023 13:33
Found In Egroup: Regulatory Open Forum \ view thread
Hello, I wanted to gain some insight into the EU MDR Patient Implant Card requirement for Implantable Accessories. The accessories are implanted in the brain along with the main device. Do we need to have a PIC card for accessories such as connectors, clips, fixation tabs, and tubing plugs? ...

RE: Peer review opportunities

Posted By Shikha Malik 15-Sep-2023 17:16
Found In Egroup: Regulatory Open Forum \ view thread
Hi, Thank you for the reply. I am looking for activities involving peer-review for journals, and articles and may be as a part of an organization or society. Regards, Shikha ------------------------------ Shikha Malik Sr. Regulatory Affairs Specialist Frisco TX United States ---------- ...