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Medfins International is your one stop solution for guiding you through Medical Device Services
End-to-End Solutions for Regulatory Compliance and Clinical
Trials — Tailored for Pharma, Biotech, Medical Devices,
IVDs, Food & Cosmetics
At Medfins International, we don’t just help you meet regulatory requirements — we help you unlock new markets and opportunities. Our expert team specializes in providing end-to-end regulatory solutions for medical devices, ensuring smooth approvals and certifications across the globe. With a focus on precision, speed, and compliance, we work as your trusted partner to navigate international standards and licensing processes. Whether you’re seeking CE Marking, US FDA clearance, CDSCO approvals, or global certifications, Medfins is committed to helping your products reach patients safely and efficiently. Let’s bring your medical innovations to the world with confidence.
Our Services
To redefine the regulatory streamline, making it as dynamic, innovative, and future-forward as
the products we help bring to life. Your success is our mission.
At Medfins, we ensure your medical devices and healthcare products fully comply with national and international regulatory standards. From CDSCO to US FDA and EU MDR, our experts help you navigate complex regulations to achieve safe, effective, and legally compliant market access.
Accelerate your time to market with strategic regulatory planning, accurate documentation, and streamlined submission processes. Medfins facilitates faster approvals by identifying potential regulatory roadblocks early and ensuring efficient coordination with authorities.
We implement ISO 14971-compliant risk management frameworks to identify, analyze, and mitigate risks throughout your product’s lifecycle. Our proactive approach ensures both patient safety and regulatory readiness.
Medfins supports market entry into multiple regions, leveraging our knowledge of local and international frameworks (CDSCO, US FDA, EU MDR, etc.). Expand your business with confidence.
Get expert input during R&D and product design. Our consultants align your development process with key standards like ISO 13485, ISO 14971, and GMP, reducing rework and maximizing regulatory success.
Our team supports you beyond approvals—managing post-market surveillance, license renewals, product variations, and periodic reporting. Stay compliant throughout your product’s life.
WE ARE TRUSTED
Medfins International was born out of a critical need – to bridge the gap in regulatory compliance during the product development stage in the medical device sector.
With a crew of regulatory experts and a commitment to cutting-edge solutions, we’re here to make your medical devices shine on the world stage.
I’m delighted to share my experience with Medfins International. Their expertise and guidance were instrumental in helping Medixa Global LLP achieve ISO 13485 certification. The team at Medfins International provided us with clear and concise information, tailored their approach to our specific needs, and supported us throughout the certification process. Their dedication and professionalism ensured we met all the requirements and passed the certification audit successfully. I highly recommend Medfins International to any organization seeking to implement a robust quality management system.
Posted on Google
September 30, 2023
As an importer of dermatological lasers and cosmetics, we have successfully obtained the COS-2 certification and are currently in the process of securing our import license for Class C products. Additionally, we are preparing to apply for licenses for more products as we expand our portfolio. Mr. Arun and his team were incredibly supportive throughout the process, their expertise has been invaluable, and we look forward to continuing our collaboration for future regulatory requirements.
Posted on Google
February 24, 2023
We have collaborated with Medfins International for ISO 13485 compliance. My experience with their service was outstanding. I highly appreciate the professionalism and efficiency displayed. I would gladly give a high rating and confidently recommend your services to others. Keep up the excellent work.
Posted on Google
August 10, 2023
We selected Medfins International as our Indian Authorized Agent for our medical device. Their communication was clear and concise throughout the process. The services they provided were of high quality and met our expectations. We would definitely recommend their services to others.
Posted on Google
July 27, 2023
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