Empowering The MedTech Industry. Every Step of The Way.

Enable your company to enter new markets with fully complaint products with complete ease. Cruise through your regulatory journey with us.

We've been at this a long time

Founded in 2016 in Miami, Florida, KN Consulting was born from the desire to streamline complex regulatory processes in the rapidly changing and highly-competitive regulatory landscape. Our team, made of science, quality and regulatory experts, serve medical device, IVD, SaMD and pharmaceutical manufacturers. Our services cover complete range of pharmaceuticals and medical devices.

20+

Regulatory Affair Enthusiasts working towards a common goal

50+

Regulatory submissions successfully completed

OUR CORE VALUES

What Do We Believe In

These three values bind us as ONE and lie at the heart of everything we do and everything we are.

Integrity

While dealing with our clients and regulatory agencies, we infuse every action with unequivocal ethical standards.

Innovation

We strive to be truly agile and lean in our operations to eliminate all regulatory and quality complexities within the MedTech industry.

Client Focus

We are committed to providing interdisciplinary expertise to our clients. Be it rapid global market access, regulatory pathway.

FOUNDER'S MESSAGE

Meet the founder

Agility and Innovation: The Way Forward

We have evolved from a team of two to a group of highly qualified individuals. I'd like to take this opportunity to express my gratitude towards our faithful clientele for being the part of this success.

This is an exciting time at KN Consulting and Services. We have grown tremendously and are eagerly looking to grow leaps and bounds in the years to come.

Karthik Natesan

CEO & Director

Roadmap

Our Journey this far

2016

KN Consulting and Services is born

2017

Set up our office

Opened our first office in Miami, Florida Expanded to a team of Five

2016 - 2018

Our First Client

Our very first client - A Fortune 500 company Worked successfully with Terumo Medical Corporation for three consecutive years.

2018

Worked with our first Start-Up client - MedAnswers

Successfully assisted them to identify the Regulatory Pathway for their Fertility wellness kit application.

2019

Set up our first branch

We set up our first branch in Bangalore, India and bolstered our team to grow further.

2019-2021

Business/Clientele Expansion

Entered the European markets and assisted our clients with EU MDR & EU IVDR. Worked with many different clients of all sizes.

2021

Team expansion and diversification

Expanded to a bigger team Biomedical Engineers, Mechanical Engineers, Software Engineers, and personnel with interdisciplinary exposure to assist our clients better.

2022

Entry into the Canadian Market I Forthcoming Outlook

Assisted Alma Lasers to a Health Canada regulatory compliance and submission. Looking to leverage technology and innovation to better assist companies intostreamlining their regulatory & quality affairs moving forward.

2016
2017
16-18
2018
2019
19-21
2021
2022

Hop on this transformational journey with us.

Contact Us