At Sushvin Consultancy Services, we are dedicated to guiding medical device companies through the intricate landscape of global regulations. Founded in 2011 by Aditya Kulkarni, we are committed to delivering customized, cost-effective solutions that ensure compliance with international standards for medical devices and in-vitro diagnostics.
With over a decade of experience, our team possesses deep knowledge across various sectors, including Advanced Wound Care, Software as a Medical Device (SaMD), Dental Implants, Orthopedics, Drug-Device Combination Products, and In Vitro Diagnostics. We specialize in Quality Assurance and Regulatory Compliance, adeptly navigating the ever-evolving regulations in the UK, EU, US, Middle East, South Asia, and beyond.
We aim to empower our clients by keeping them informed and compliant amidst the ever- changing global medical device regulations. Our goal is to simplify compliance processes, saving our clients time and resources, and enabling them to concentrate on innovation and growth.
Our vision is to be a global leader in regulatory compliance for the medical device and healthcare industries, driving innovation, safety, and seamless market access.
We pride ourselves on simplifying the regulatory process for our clients. By fostering strong, collaborative relationships, we gain a comprehensive understanding of each client's unique challenges and objectives. This enables us to provide tailored solutions that alleviate the complexities of compliance, allowing our clients to focus on their core business activities.
We’re not just another consulting firm—we’re your strategic partner in navigating the ever- changing world of medical device regulations. Let us handle the paperwork while you change lives.
Our team comprises seasoned professionals who bring diverse expertise to the table. From regulatory affairs to quality assurance, each member is dedicated to delivering exceptional service and outstanding results. We believe that our collective knowledge and collaborative approach are key to our clients' success.
Principal Consultant
Principal Consultant
QARA Consultant
QARA Consultant
QARA Consultant
As a proud member of the Association of British HealthTech Industries (ABHI), we align ourselves with the UK's leading industry association for health technology. This affiliation underscores our commitment to supporting the HealthTech community in delivering products and services that enhance people's lives.
In addition, Sushvin Consultancy Services has partnered with LSCOPE to deliver guest lectures on regulatory affairs, sharing knowledge and insights with professionals and aspiring regulatory specialists. Through this collaboration we enhance industry education and promote a profound understanding of global regulations surrounding medical devices and healthcare.
Join us to turn regulatory challenges into opportunities. Contact us today for a free consultation.
Clients Across The Globe
Devices Regulated
Years Of Experience
Sushvin provides a wide range of services designed to cater to the diverse needs of our clients. Our extensive service offerings include:
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