Meet us at Medica 2025

WHX Miami 2025
Premium Services

Trusted Experts in Global Medical Device Regulations

We help medical device manufacturers meet global regulatory requirements through our specialized services — all aligned with international standards and industry best practices.

CE Marking

Empowering Your Journey to Market –
Trusted Experts in Medical Device
CE Certification.

USFDA & 510k Submission

Navigate the US Market with Confidence – Expert Support for Your 510(k) and USFDA Submission Needs.

Indian MDR

Regulatory Confidence Starts Here –
Expert Support for Your
Indian MDR Success.

Quality Management System

Driving Excellence, Delivering Trust — Your Ally in Robust Quality Management Solutions.

CER Writing

From Clinical Data to Regulatory
Confidence — Your Trusted
CER Writing Partner.

Premium Organizational Management

Empowering and Elevating Your Quality & Compliance Systems with Precision!

Our Expertise

Your trusted partner for regulatory success — we help medical and IVD device manufacturers meet global standards with precision, speed, and cost-efficiency.

  • Regulatory Submissions & Approvals:
    • CE Marking (MDR / IVDR)
    • USFDA 510(k)
    • MDSAP Certification
    • MD-QMS (ISO 13485 & 21 CFR Part 820)
    • Indian MDR
  • Specialized Documentation Services:
    • Clinical Evaluation Reports (CER)
    • Post Market Surveillance (PMS)
    • Risk Management files (RMF)
    • Usability Engineering File (UEF)
    • Medical device software file (SMF)
  • Premium Organizational Management:
    • Fully outsource your Regulatory Affairs and Quality Assurance functions to our expert team — allowing you to focus on innovation while we manage compliance.
Medical Devices Regulatory Consulting
Medical Devices Regulatory Consulting

Driven By Expertise, Empowered By Innovation

At MAVEN, our strength lies in a passionate team of forward-thinking professionals who turn complex regulatory challenges into smart, actionable solutions. From regulatory consulting and auditing to medical device engineering, quality assurance, and business intelligence, we deliver trusted, modern support to clients around the world.

We believe that great results come from great people. That’s why we nurture a work culture where innovation thrives, talent grows, and work-life balance is valued. This empowering environment helps our team achieve more — and ensures our clients receive scalable, high-impact results with unmatched consistency.

Get Started Today!

WHY PARTNER WITH US?

Tap into the expertise of seasoned consultants who know medical device regulations inside out — so your journey stays on track, stress-free, and fully aligned with global standards.

Industry Experts

Industry
Specialists

Our team comprises over 100 dedicated experts, each bringing deep knowledge and extensive qualifications in medical device regulations, focused on delivering precise and dependable solutions tailored to our clients’ needs.

Tailored Solutions

Custom
Solutions

We deliver custom-crafted services focused on safeguarding your
data privacy, ensuring prompt
project delivery, and offering
full support—ranging from
on-site visits to audit
assistance.

Comprehensive Services

All-in-One Regulatory
Services

We provide a wide range of regulatory services
under a single roof, tailored
to support our clients in
meeting their specific
global regulatory
requirements.

Dedicated Project Manager

Committed
Project Manager

At MAVEN, we don’t just
consult — we stand by
your side as dedicated
partners, providing unwavering
support throughout every step
of your medical device
regulatory path.

Success Stories
Straight from Our Powerhouse Partners

See how our teamwork and expertise crush regulatory hurdles and fuel breakthrough medical device innovations.

Highly Professional
Team!

I am writing to express my gratitude and appreciation for the exceptional services provided by our consultant team- Maven, particularly the MDSAP & CE team. Their proactive approach, attention to detail, and strong support have exceeded our expectations at every turn. I wholeheartedly recommend Maven team to any organization seeking top-tier consulting services. Their hard work, high commitment, and exceptional knowledge make them an invaluable asset to any project.

We look forward to continuing our successful collaboration in the future.

Quote
Duyen Ho
Micro Medical Devices Inc.

Impressive Regulatory
Expertise!

I would like to appreciate level of service we’ve received from “Maven Profcon Services LLP” as highly professional, competent and proactive, maintaining agreed terms and at reasonable budget.



In addition to their technical expertise, the team's professionalism and cooperative spirit have made working with them a genuine pleasure. Their proactive approach, attention to detail, and strong support have exceeded our expectations at every turn.

Quote
Regimants Baranovskis
SIA Simurg Balticum

Provide Premium
Services!

I just wanted to let you know that "Maven Profcon Services LLP" team has been doing a tremendous job in providing best consulting services in the filed of Medical Device. They are having a big team of qualified and experienced experts to coop up and fulfill all requirements of Medical Device Directives(MDD), We appreciative all their effort and engagement in providing us the right solutions for our all requirements.


We wish them all the best for their all future assignments.

Quote
S.K. Rowther
Hardik International Pvt.Ltd

Meet The
Regulatory Rockstars

Masters of the maze, our sharp pros cut through medical device rules with precision — driving your success with skill and swagger.

Yogesh Dad

Yogesh Dad

Director
Maulik Patel

Maulik Patel

Vice President