20+ Global Clients Served
Services
How We Help
Regulatory Compliance
Whether it's the approval process or post-approval support, we ensure seamless regulatory compliance for your device throughout its life cycle. We have experts in US FDA and EU MDR/IVDR, Health Canada, UKCA and other global regulations.
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Quality Assurance
We pride ourselves on being quality experts, passionate abouthelping you meet high quality and sustainable Quality Management Systems.
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Product Development
With our experience & know-how in building & updating devicedesign history, expect a simple yet strategic device remediation approach..
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USPS
What Sets Us Apart
Innovation
Bespoke solutions while adapting at hyper speed and thinking on our feet
Commitment
Uncompromising dedication to Commitments, Compliance and Quality
Experience
Breakthrough Excellence with proven global experience
Above & Beyond
Perfection throughout the Journey, to the Goal
Hire At KN
Assemble your dream team with KN Consulting.
We’re here to help you build a solid offshore team of dedicated Quality Assurance and Regulatory Compliance professionals.
TESTIMONIALS
What Our Customers Say
Alex Bourdon / IVDR Leader - Siemens Healthineers
“Excellent!! As I told Andrea and Jennifer Huff, you have been highly valuable, delivering on your commitments and helping other groups regardless of organizational boundaries.”
William Erdmann / Director – Terumo Medical Corporation
“The intricate detailing and creation of Master TMV Memorandums were some major difficult things to allocate altogether. I am extremely happy with your firm for successfully completing the project within the timeline.”
Jessica Rivera-Montejo / Director ‑ Regulatory and Quality (Alma Lasers)
“We really enjoyed working with Karthik and his team. We had 2 submissions to Health CA side by side, with the expectation of both going in within a pretty tight timeframe. The team was very organized, and held weekly touchpoints to discuss outstanding items and to track progress through in order to meet the deadlines. We were successful with both of the submissions with minimal questions from Health CA. I would recommend KN Consulting services to anyone that is looking for a great team to support them with submissions. We will be using their team again for future plans for sure!”
Viky Verna / Co-Founder and VP - Confinis
“Very good, very thorough, comprehensive and addresses all the main points. Assessment based on the primary principles of operation and product capabilities.”
RESOURCES
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Hop on this transformational journey with us.
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