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About Us
At Pristine Med Solutions, we empower medical device and diagnostics companies to succeed in a rapidly evolving regulatory landscape. As a trusted consulting partner, we leverage our team's expertise in biomedical engineering and regulatory affairs to deliver customized solutions that address each client's distinct challenges and goals. Our mission is to simplify regulatory complexity, ensuring that our clients can focus on innovating and delivering life-changing medical solutions. Our team has in-depth knowledge of regulatory requirements, including:
• FDA regulations (21 CFR)
• EU MDR and IVDR
• ISO 13485 and ISO 14971
• CDSCO and DCGI guidelines (India)
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Who we are
Founded by three visionary friends, Pristine is dedicated to empowering businesses to achieve seamless regulatory compliance and ISO standard implementation. Our passion for quality and efficiency drives us to deliver customized solutions that:
• Simplify compliance management
• Enhance operational efficiency
• Exceed regulatory requirements
With expertise in international standards such as ISO 13485, ISO 14971, IEC 62304, and FDA guidelines, as well as in-depth knowledge of Indian regulations, including:
• CDSCO (Central Drugs Standard Control Organization) regulations
• DCGI (Drugs Controller General of India) guidelines
We provide comprehensive support to our clients, ensuring they meet the requirements of the Indian regulatory landscape. Our proactive and integrated approach prioritizes:
• User safety and well-being
• Building trust in the marketplace
• Driving sustainable improvements
At Pristine, we're committed to helping businesses thrive in a rapidly evolving regulatory landscape.
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Regulatory Experts
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Legal Advisors
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Industry Veterans
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Biomedical Engineers
Founded
2024
Employees
10+
Countries
12
Why Choose Us
At Pristine Med Solutions, we bring a wealth of experience and a commitment to excellence in navigating the complex landscape of medical device regulations. Our team of experts is dedicated to ensuring your success in the global market.
Expertise
Leveraging years of industry knowledge, we offer unparalleled expertise in CDSCO regulations.
Efficiency
Our efficient processes and proactive approach reduce the time and effort required for registration.
Client-Centric
We prioritize our clients’ needs, providing personalized solutions tailored to each project.
Our Mission & Vision
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Our Mission
At Pristine Med Solutions, our mission is to empower medical device and diagnostics companies by providing expert regulatory guidance, comprehensive quality management solutions, and unwavering support throughout the product lifecycle.
Our Vision
To be the leading global partner in regulatory and quality consulting, empowering medical device companies to innovate and bring life-changing solutions to market with confidence and compliance.
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