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Premium Services

Specialized Support in Worldwide Medical Device Regulations

Our expertise lies in fulfilling international medical device regulatory demands, emphasizing core services aligned with global standards.

CE Marking

Your Trusted Pathway to
Medical Device Approval and
Market Readiness.

USFDA & 510k Submission

Accelerating Your Device's Market Entry with Trusted USFDA & 510(k) Submission Expertise.

Indian MDR

Powered by Proven Expertise –
Your Trusted Route to
Regulatory Success.

Quality Management System

Driving Quality, Fueling Growth – We Build Robust Quality Management Systems That Deliver Results.

CER Writing

Turning Clinical Evidence
into Regulatory Success – Your
Trusted Partner in CER Writing.

Premium Organizational Management

Shaping and sustaining your Regulatory & Quality systems with precision and care!

Our Expertise

We help bring your medical and IVD devices to market swiftly and affordably—meeting global regulatory standards with precision.

  • We handle regulatory submissions and documentation for:
    • CE Marking (MDR/IVDR)
    • USFDA 510(k) submissions
    • MDSAP audits
    • MD-QMS (ISO 13485 & 21 CFR Part 820)
    • Indian MDR
  • We also craft or update key technical documents:
    • Clinical Evaluation Reports (CER)
    • Post Market Surveillance (PMS)
    • Risk Management files (RMF)
    • Usability Engineering File (UEF)
    • Medical device software file (SMF)
  • Premium Organizational Management:
    • Looking to scale smart? Entrust your entire Regulatory Affairs (RA) and Quality Assurance (QA) functions to us—we act as your extended team with premium organizational support.
Medical Devices Regulatory Consulting
Medical Devices Regulatory Consulting

Driving Regulatory Success Through People and Innovation

At MAVEN, our strength lies in a passionate team that thrives on innovation and delivers measurable results. With deep-rooted expertise in regulatory affairs, audits, medical device engineering, quality systems, and business intelligence, we craft cutting-edge solutions tailored to global client needs.

We foster a culture where talent flourishes—balancing challenge with support and ambition with well-being. This enables our professionals to perform at their best, ensuring our clients benefit from smart, scalable, and reliable outcomes—all backed by our commitment to excellence and a healthy work-life environment.

Get Started Today!

WHY PARTNER WITH US?

Work with us and gain the advantage of seasoned experts who understand the ins and outs of medical device regulations—guiding you every step of the way toward confident compliance.

Industry Experts

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

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

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

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.

Success Stories
Shared by Our Valued Partners

See how our teamwork and expertise have empowered clients to navigate regulatory hurdles and drive breakthroughs in medical device innovation.

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 Our Skilled
Regulatory Team

Our experienced professionals are committed to helping you through the complex world of medical device rules, making sure you succeed every step of the way.

Yogesh Dad

Yogesh Dad

Director
Maulik Patel

Maulik Patel

Vice President