Medical Devices Regulatory Consulting Services

ABOUT US

At Maven Profcon Services LLP, we are committed to helping medical device manufacturers to 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/in vitro diagnostic devices (IVDs) 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 SERVICES

CE CERTIFICATION CONSULTANCY
CDSCO APPROVALS FOR MEDICAL DEVICES
US FDA 510(k) APPROVAL FOR MEDICAL DEVICES/IVDs
UKCA CERTIFICATION CONSULTANCY
OTHER REGULATORY CONSULTANCY

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

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

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

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

Services We Offer for Medical Device/IVDs Regulatory Requirements

CUSTOMERS ARE SAYING

Mr. Hem Patel

Sr. QA Executive,
Miraclus Orthotech Pvt. Ltd.

MAVEN’s Medical Device regulatory services have consistently impressed us with their technical expertise, timeliness, and tailored solutions. Their proactive approach to regulatory updates, clear communication, and effective problem-solving skills have been invaluable. Their compliance success, and training offerings have greatly benefited us. I wanted to appreciate the hard work, approach and association during audit which MAVEN team has put forward in our organization. Your regulatory support on single call is always value added.

Mr. Mahesh Godhasara

Samay Surgical

The Maven team are ultimate rock stars! They are a highly professional, educated and experienced team that is dedicated to helping their clients achieve success. One of the best teams I have ever worked with – highly responsive, innovative and leverage best practices. From kick-off to project completion, they never miss a beat
and are always there to answer questions and provide intelligent insight. They have been consulting for ISO 13485 and CE certification. They also provide Annual Contract facility for the same. Looking forward to many more projects ahead!

Mr. D. K. Sharma

Sharma Pharmaceuticals Pvt. Ltd.

We are very glad to have Maven as our regulatory consultant or you may say regulatory partner, Maven has not only eased our process but always strive for process improvements with practical approach.

Maven methodology & dedicated team for each project / client really helps in customer focus & valuable recommendations.

Nirav Khunt

EON Meditech Pvt Ltd . – Technical Director

We have been using your services since 2017 and very satisfied with services. Maven has helped us to get 2 CE certificates and update QMS according to the latest regulatory requirement. We are also working with other projects like CDSCO registration and get very positive support from your team.

Working with Maven has been hassle-free and there were barely any follow-ups required. The team has always efficiently & timely conveyed all the deliverables and made sure we provide data on time and kept us on our toes which we liked about them very much. Timely arrival of required certifications and therefore enhancing our business process This led to our clients being highly impressed by the efficiency & punctuality which resulted in the completion of the project on time without any turbulence. Keep up the wonderful work & strong ethics.

Mr. Hemant Koradia

Meghdoot Pharma

Maven have supported us during the time of our all regulatory needs, and that too with all the dedication and sincerity. Despite our several phone calls there has never been a voice of irritation from your side. Every problem was replied with absolute calmness and respect.

Our best wishes for your vertical growth in this field.

Mr. S.K. Rowther

Hardik International Pvt.Ltd

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.

Mr. Pradeep Trivedi

Ortho Max Mfg’ Co’ Pvt’ Ltd’

“I just wanted to let you know that your team has been doing a tremendous job on our request. They are turning things around quickly, coming up with approaches and suggestions on their own and are truly partnering with us on different initiative. We are deeply appreciative of all their effort and engagement.”

I wanted to take this opportunity and appreciate the hard work Maven team has put in getting our CE certification. This was especially challenging given short turnaround time

Mr. Ranjit Gaikwad

Pregna International Ltd

“Maven Profcon Services LLP” has been very professional in their work with us at “Pregna International Ltd.” The Team was able to quickly grasp what we wanted to accomplish and had some great ideas on how to achieve our goals through 1st official MDR training. They have a wide variety of implementation scenarios in their background that they could draw information from the demo that they put together with great example was well received. It generated a lot of interest and knowledge for the upcoming Medical Device Regulation. We highly recommend “Maven Profcon Services LLP” for any type of Medical Device Regulatory Services.

Mr. Dinesh Pokhariyal

Griportho Surgicals Pvt. Ltd.

We consider MAVEN PROFCON SERVICES LLP as an associate concern of Griportho and we have always counted on you for all our regulatory requirements. We shall always admire the way your support mechanism is in place with prompt responses & correct advices.

Mr. Regimants Baranovskis

SIA Simurg Balticum

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.

Medical Devices & IVD Regulatory Consulting Services

Expert Support for Medical Devices & IVD Approvals

CE Marking For Medical Devices

CE Marking For In-Vitro Diagnostic Device

USFDA & 510k Submission For Medical Devices

Medical Device Quality Management Systems

Clinical Evaluation For Medical Device

CE Marking For Medical Devices

USFDA & 510k Approval For Medical Devices

Indian MDR (CDSCO) For Medical Devices

Medical Device Quality Management System

Clinical Evaluation for Medical Devices

ABOUT US

OUR SERVICES

CE Certification Consultants for Medical Devices

CE Marking for In-Vitro Diagnostic Device

Post Market Surveillance for Medical Devices

Risk Management for Medical Devices

Clinical Evaluation for Medical Devices

MDR Gap Analysis

European Authorized Representative Services

Unique Device Identification for Medical Devices

Medical Device Quality Management System

European Database for Medical Devices

Benefit-Risk Analysis for Medical Device

Biological Evaluation of Medical Devices

Test License for Medical Devices

Medical Device Manufacturing License

Medical Device Import License

Free Sales Certificate for Medical Device

US FDA 510k Consultant

FDA Food Facility Registration

FDA Drug Establishment Registration

FDA Cosmetic Registration

US FDA Agent

US FDA Label

Registration and Listing of Medical Device

UKCA Marking for Medical Devices

Risk Management for Medical Devices

MHRA Registration for Medical Devices

UK Responsible Person for Medical Device

Clinical Evaluation Services for Medical Devices

Medical Device Establishment Registration

Medical Device Quality Management System

Annual Maintenance Contract for Medical Device

MDSAP Certification

Medical Device Turnkey Services

Medical Device Quality Audit

MRM for Quality Management

Training for CE Marking

Medical Device Process Validation

ISO 13485 Certification

ISO 9001 & ISO 13485 - IQMS

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

What Our

CUSTOMERS ARE SAYING

Mr. Hem Patel

Mr. Mahesh Godhasara

Mr. D. K. Sharma

Nirav Khunt

Mr. Hemant Koradia

Mr. S.K. Rowther

Mr. Pradeep Trivedi

Mr. Ranjit Gaikwad

Mr. Dinesh Pokhariyal

Mr. Regimants Baranovskis

Start Your CE Certification Journey with our Expert Regulatory Support

Our Blogs

LATEST NEWS

CE Approval for Vacuum Blood Collection Tubes Under IVDR

SaMD – Software as a Medical Device: EU MDR Rule 11 Classification & CE Marking

CE Certification for Contact Lenses: Ensuring Safety, Quality, and Market Readiness

We Are Global As Regulatory Consultant

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