Profile

Karthik Natesan, RAC

Contact Details

United States

Contributions

1 to 5 of 9 total

RE: CER Writer

Posted By Karthik Natesan, RAC 27-Dec-2023 00:46
Found In Egroup: Regulatory Open Forum \ view thread
Hello Rebecca - I'll be happy to assist you with writing a CER for Class IIa device. Feel free to reach out to me at kn@knconsultingandservices.com We can discuss more about the CER over a zoom call. Thanks ------------------------------ Karthik Natesan, RAC KN Consulting and Services (Quality ...

RE: Growth Factor in Animal Tissues/ Medicinal Product

Posted By Karthik Natesan, RAC 18-Nov-2021 03:52
Found In Egroup: Regulatory Open Forum \ view thread
Thanks a lot for your feedback Niraj! Will look into Cook Biotech's Porcine SIS graft. Best Regards, Karthik ------------------------------ Karthik Natesan, RAC KN Consulting and Services (Quality and Regulatory Consultant) Newark, DE P: 949-245-5607 ------------------------- ...

Growth Factor in Animal Tissues/ Medicinal Product

Posted By Karthik Natesan, RAC 17-Nov-2021 00:07
Found In Egroup: Regulatory Open Forum \ view thread
Hello Friends - I have a question about growth hormones/ growth factors which are naturally present in the Animal tissues. Our product uses  animal tissue which has growth factors and it is applied on the human body and is absorbed by the human body locally. For complying with MDR 2017/245, do we ...

RE: Device risk management flowchart (EN ISO 14971:2019 and MDR)

Posted By Karthik Natesan, RAC 17-Feb-2020 12:08
Found In Egroup: Regulatory Open Forum \ view thread
Hi Rob and Sam - I agree that companies struggle with the acceptability policy and the benefit/risk analysis. An acceptability policy based upon the quantitative analysis of the cumulative individual benefit/risk analysis will be cumbersome for the companies as different product lines would have different ...

RE: Device risk management flowchart (EN ISO 14971:2019 and MDR)

Posted By Karthik Natesan, RAC 14-Feb-2020 05:26
Found In Egroup: Regulatory Open Forum \ view thread
Hi Sam - This is an excellent flow chart. I agree with the contents that you have got there. Karthik Natesan ------------------------------ Karthik Natesan, RAC KN Consulting and Services (Quality and Regulatory Consultant) Newark, DE P: 949-245-5607 ------------------------------