Meet us at ARAB HEALTH 2025

Arab Health 2025
Premium Services

Expert Guidance in Global Medical Device Regulations

We specialize in meeting global medical device regulatory requirements, with a strong focus on the following key services that adhere to international standards.

CE Marking

Navigating Excellence: Your Partner
in Medical Device CE Marking
Success.

USFDA & 510k Submission

Empowering Your Medical Device Journey: Expert USFDA & 510(k) Submission Guidance.

Indian MDR

Navigating Compliance with
Expertise: Your Gateway to
Indian MDR Success.

Quality Management System

Building Excellence, Ensuring Quality: Your Partner in Effective Quality Management Systems.

CER Writing

Transforming Data into
Compliance: Your Dedicated
CER Writing Solution.

Premium Organizational Management

Nurturing your Regulatory & Quality Management System for you!

Our Expertise

We ensure your medical and IVD devices achieve compliance with relevant regulations efficiently and cost-effectively.

  • Regulatory Submissions & Documentation for:
    • CE Marking (MDR/IVDR)
    • USFDA 510(k)
    • MDSAP
    • MD-QMS (ISO 13485 & 21 CFR Part 820)
    • Indian MDR
  • Specific Document creation or updating:
    • Clinical Evaluation Reports (CER)
    • Post Market Surveillance (PMS)
    • Risk Management files (RMF)
    • Usability Engineering File (UEF)
    • Medical device software file (SMF)
  • Premium Organizational Management:
    • Outsource your Regulatory Affairs (RA) & Quality Assurance
      (QA) department to us.
Medical Devices Regulatory Consulting
Medical Devices Regulatory Consulting

Achieving Regulatory Excellence

At MAVEN, our dedicated team of innovative and results-driven professionals is the cornerstone of our success. We deliver modern solutions and exceptional service to clients worldwide, leveraging extensive expertise in regulatory consulting, auditing, medical device engineering, quality assurance, and business intelligence.

We are committed to empowering our staff to reach their full potential within a supportive and competitive environment. This approach fosters higher productivity and enables us to provide robust, scalable solutions and guaranteed results for our clients, all while maintaining a healthy work-life balance.

Get Started Today!

WHY PARTNER WITH US?

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

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.

Voices of Success
Stories from Our Esteemed Partners

Explore how our collaborative approach and expertise have enabled clients to overcome regulatory challenges and advance 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 Adept
Regulatory Maestros

With deep expertise and a commitment to excellence, our dedicated professionals navigate the complexities of medical device regulations to guide your success.

Yogesh Dad

Yogesh Dad

Director
Maulik Patel

Maulik Patel

Vice President