Maven

ABOUT US

At Maven Profcon Services LLP, we help medical device and IVD manufacturers navigate complex global regulations with tailored, reliable consulting solutions. Since 2016, we’ve supported 300+ clients—from startups to multinationals—by combining expert guidance, personalized service, and global regulatory insight to ensure smooth approvals and ongoing compliance across all major markets.

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40+

Annual Maintenance
Clients

100+

Medical Devices Quality Management System

50+

CE Certification

30+

US FDA 510(k)

OUR SERVICES

We are global medical device regulatory consultants providing expert regulatory consulting services to medical device and in vitro diagnostic device (IVDs) manufacturers. We support manufacturers in completing conformity assessments by assisting with Technical documentation preparation & review, mock audits, and on-site audit support. Our services cover document preparation of clinical evaluation, post-market surveillance, risk management, GSPR, Identification of Testing requirements, free sales certificate, and more. Our goal is to help manufacturers ensure medical devices & in vitro diagnostics meet regulatory requirements and achieve faster approvals with ease.

Services We Provide Under CE Certification Consultants

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As leading medical device regulatory consultants, providing expert consulting services to help medical device manufacturers meet regulatory requirements with ease. Our team supports medical device manufacturers in obtaining various CDSCO approvals, including Test License, Manufacturing License, Import License, Loan License, and more. With deep understanding of Indian medical device regulations, we assist at every step to ensure smooth approvals, faster market access, and complete regulatory support for all your medical device registration needs.

Services We Provide Under CDSCO Regulatory Framework

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Recognized internationally as medical device regulatory consultants providing expert support to medical device and IVD manufacturers seeking entry into the US market. Our services include US FDA 510(k) submissions, Drug Establishment Registration, US Agent services, and other essential regulatory solutions. We help manufacturers navigate the complex FDA requirements with ease, ensuring timely approvals and full regulatory compliance for a smooth market launch.

Services We Offer as US FDA 510(k) Consultants

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At Maven Profcon Services LLP, we specialize in providing expert UKCA Certification Consultancy services for medical device/In vitro Diagnostic Devices(IVDs) manufacturers. Our team assists with MHRA registration, preparation and review of technical documentation, appoint UK Responsible Persons (if needed), conformity assessment support, and labeling compliance to meet the UK regulatory requirements. We work closely with medical device manufacturers to simplify the regulatory certification process, ensuring smooth and efficient market entry into the UK.

Services We Provide For UKCA Marking

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MAVEN ON THE MOVE – GLOBAL EVENTS & EXHIBITIONS

Meet us at WHX Miami, 11-13 June 2025, Miami Beach Convention Center, Florida, United States

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Meet us at Medica, 11-20 November 2025, Düsseldorf Germany

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Meet us at WHX Dubai, 9-12 February 2026, Dubai Exhibition Centre, United Arab Emirates

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CHOOSE MAVEN, CHOOSE CONFIDENCE

Our experienced consultants possess extensive knowledge of medical device regulations, ensuring that your path to compliance is expertly guided.

Industry Experts

A dedicated team of 100+ specialists with extensive experience and qualifications in medical device regulations, committed to delivering focused and resilient solutions for our clients.

Tailored Solutions

We provide tailored solutions that prioritize client data confidentiality, ensuring timely execution and comprehensive support, including on-site visits and audit assistance.

Comprehensive Services

We are offering various regulatory services under one roof to help our clients meet global compliance requirements as per their needs.

Dedicated Project Manager

At MAVEN, we are more than just consultants; we are your committed partners, offering steadfast support throughout your medical device regulatory journey.

MEET THE MINDS DRIVING MAVEN

What Our

CUSTOMERS ARE SAYING

CLIENTS WHO BELIEVE IN MAVEN

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Start Your CE Certification Journey with our Expert Regulatory Support

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Frequently Asked Questions (FAQ)

At MAVEN PROFCON SERVICES LLP, we know medical device regulations can be tricky and urgent. That’s why we’ve answered the top questions from our clients—to quickly guide you through our services and how we support your journey. Whether you’re a startup or a global manufacturer, our FAQs have you covered. Need more? Just reach out—we’re ready to help!

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What services does Maven Profcon offer?

We provide expert regulatory consulting for medical device manufacturers globally. Our core services include:

Who can benefit from your services?

We work with medical device manufacturers of all sizes – from startups with 8–10 employees to global enterprises with thousands. Whether you are entering the market or scaling internationally, our solutions are designed to meet your specific regulatory needs.

How experienced is your team?

Our team consists of highly qualified professionals with deep expertise in medical device regulations, auditing, quality systems, engineering, and market access strategy. Since 2016, we’ve successfully served 200+ clients across 10+ countries.

How do you ensure compliance with regulatory updates?

Our experts stay up to date with evolving global regulations. We proactively adapt your compliance strategies and documentation to align with the latest changes, minimizing delays and avoiding non-compliance risks.

Can I book a consultation with your team?

Absolutely. Visit our Contact Page or email us at enquiry@mavenprofserv.com to schedule a consultation with our regulatory experts.

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