Expertise in Regulatory Compliance: Your Trusted Partner

Your Expert Guide in the Medical Device Regulatory Consulting Industry

MAVEN PROFCON SERVICES LLP

At Maven Profcon Services LLP, we are committed to helping medical device manufacturers succeed in today’s complex medical device regulatory landscape. With a compassionate, professional, and highly skilled team, we deliver customized medical device regulatory consulting solutions that ensure full regulatory compliance while supporting your growth and innovation goals.

Since 2016, we’ve proudly supported over 300+ medical device manufacturers for their regulatory requirements around the world. From agile startups to large-scale multinational corporations, we bring a tailored approach to every client engagement. No matter the company size, we understand the regulatory challenges—and deliver solutions that work.

With clients across multiple time zones, we offer flexibility and support that spans continents. Our global regulatory insight, combined with personalized service, ensures you’re always a step ahead—wherever you operate.

OUR TEAM

At Maven Profcon LLP, our success is built on the strength of Team MAVEN—a passionate group of medical device regulatory consultants dedicated to helping medical device manufacturers achieve global compliance and market success. We are proud to be recognized as a trusted medical device regulatory consulting firm, known for innovation, precision, and personalized service.

Our Medical device regulatory consultant team consists of highly skilled professionals with extensive experience in medical device regulatory consulting, medical device engineering, quality assurance, regulatory auditing, and business intelligence. Many of our experts have hands-on industry experience, bringing real-world insight into every project. This combination of technical knowledge and regulatory fluency allows us to offer end-to-end support to your regulatory requirement needs, such as –

ISO 13485 Consultancy for document preparation and implementation,
Consultancy for US FDA 510(k) approval or submissions,
Consultancy for CE marking under EU-MDR/ EU-IVDR,
Preparing the Clinical Evaluation as per EU-MDR for Medical Devices
Design the performance study as per EU-IVDR for In-vitro Diagnostic devices (IVDs)

Our regulatory consultants are prepared to guide you at every step of any regulatory consulting service.

CE Certification Regulatory Consultant

We help medical device manufacturers achieve CE Certification by guiding documentation, conducting mock audits, and supporting you through the entire conformity assessment process.

CDSCO Medical Devices Registration

Expert CDSCO consultants helping medical device manufacturers obtain licenses and approvals for smooth registration and faster market access in India.

US FDA 510K Approval

Trusted FDA regulatory experts helping medical and IVD manufacturers secure 510(k) approval and enter the US market smoothly.

ISO 13485 Consulting

Expert ISO 13485 consulting for medical device companies—ensuring quality and global readiness.

MDSAP Certification

MDSAP Certification support for medical device companies—expert guidance across multiple regulatory markets.

Clinical Evaluation for Medical Device

Clinical evaluation ensures your medical device is safe, effective, and meets regulatory expectations. We help you get it right.

UKCA Certification Regulatory Consultancy

Trusted UKCA certification support for medical device companies—expert guidance from regulatory specialists.

Mission

Maven Profcon Services LLP aims at delivering regulatory compliance guidance at a groundbreaking proficiency and leading the way for Regulatory conscious businesses in the medical device fraternity while helping customer’s unique experiences in regulatory consultancy. Our mission is driven by the thought of exploring a local business niche and provide easy access to international practices and serve the unmet needs of all Medical device manufacturers globally.

Vision

To be a pioneering, interactive, consumer-driven, and zealously referred, leading medical device consultancy with a dynamically evolving scope of regulatory services for catering to the needs of our customers and creating a large cliental of loyal customers. Our vision is to continue exploring global trends in Regulatory services, lead by example, and justify being MAVEN, by being the connoisseurs of medical device regulatory field.

Policy

Maven Profcon Services LLP is engaged in providing the most accurate & best in time medical device consultancy with a closely knitted team. Customer commitment, Integrity, Optimum quality, confidentiality and the zest of leading are our core values. We offer an open-door policy to our employees where ideas and innovations are fostered into intangible assets and delivered to the clients. “We are a client relief organization, who happen to offer regulatory expertise”

EXPERIENCE. EXPERTISE. EXCELLENCE.

About Us

Your Expert Guide in the Medical Device Regulatory Consulting Industry

MAVEN PROFCON SERVICES LLP

OUR TEAM

We provide true solutions

WHY CHOOSE?

CE Certification Regulatory Consultant

CDSCO Medical Devices Registration

US FDA 510K Approval

ISO 13485 Consulting

MDSAP Certification

Clinical Evaluation for Medical Device

UKCA Certification Regulatory Consultancy

Mission

Vision

Policy

MEET THE MINDS DRIVING MAVEN

Let’s Introduce With Our Team

MEET THE TEAM

Yogesh Dad

Maulik Patel

Mishika Jaiswal

Khushboo Chhajer

CE CERTIFICATION CONSULTANCY FOR MEDICAL DEVICE

CDSCO APPROVALS FOR MEDICAL DEVICES

US FDA 510(k) APPROVAL CONSULTANCY

UKCA CERTIFICATION REGULATORY CONSULTANCY

OTHER REGULATORY CONSULTANCY