Profile

Vidya Jayaraman

Contact Details

United States

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1 to 5 of 50+ total
Posted By Vidya Jayaraman 07-Oct-2021 11:43
Found In Egroup: Regulatory Open Forum
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Congrats to the group! I'd be interested too to join the group. ------------------------------ Vidya USA ------------------------------
Posted By Vidya Jayaraman 07-Oct-2021 11:38
Found In Egroup: Regulatory Open Forum
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Difficult to answer without knowing what kind of devices you make (US and EU classes differ, different registration pathways, conformity requirements and certificate maintenance needs depending on classification), regions you are interested in marketing (N. America vs EU vs APAC), whether you are OEM ...
Posted By Vidya Jayaraman 30-Aug-2021 15:11
Found In Egroup: Regulatory Open Forum
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Hello Anon, I agree with Richard that 15223 book symbol is more general and you may want to consider what is needed specifically for your product label and users. You can add the website next to the book symbol on your labels and DFU symbol glossary . However, wanted to point out that the latest revision ...
Posted By Vidya Jayaraman 30-Aug-2021 11:19
Found In Egroup: Regulatory Open Forum
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Most likely, assuming you want to document the improved performance as an expanded indication or clinical benefit/claim in the DFU. ------------------------------ Vidya USA ------------------------------
Posted By Vidya Jayaraman 27-Aug-2021 07:24
Found In Egroup: Regulatory Open Forum
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Great post about Richard! He's a treasure! ------------------------------ Vidya USA ------------------------------