At Maven Profcon Services LLP, we help medical device and IVD manufacturers navigate complex global regulations with tailored, reliable consulting solutions. Since 2016, we’ve supported 300+ clients—from startups to multinationals—by combining expert guidance, personalized service, and global regulatory insight to ensure smooth approvals and ongoing compliance across all major markets.
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Annual Maintenance
Clients
100+
Medical Devices Quality Management System
50+
CE Certification
30+
US FDA 510(k)
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
Our experienced consultants possess extensive knowledge of medical device regulations, ensuring that your path to compliance is expertly guided.
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.
We provide tailored solutions that prioritize client data confidentiality, ensuring timely execution and comprehensive support, including on-site visits and audit assistance.
We are offering various regulatory services under one roof to help our clients meet global compliance requirements as per their needs.
At MAVEN, we are more than just consultants; we are your committed partners, offering steadfast support throughout your medical device regulatory journey.
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.
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
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.
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.
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.
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.
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!
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.
EON Meditech Pvt Ltd .
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.
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.
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.
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
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.
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.
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.
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.
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!
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.
EON Meditech Pvt Ltd .
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.
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.
At MAVEN PROFCON SERVICES LLP, we know medical device regulations can be tricky and urgent. That’s why we’ve answered the top questions from our clients—to quickly guide you through our services and how we support your journey. Whether you’re a startup or a global manufacturer, our FAQs have you covered. Need more? Just reach out—we’re ready to help!
We provide expert regulatory consulting for medical device manufacturers globally. Our core services include:
We work with medical device manufacturers of all sizes – from startups with 8–10 employees to global enterprises with thousands. Whether you are entering the market or scaling internationally, our solutions are designed to meet your specific regulatory needs.
Our team consists of highly qualified professionals with deep expertise in medical device regulations, auditing, quality systems, engineering, and market access strategy. Since 2016, we’ve successfully served 200+ clients across 10+ countries.
Our experts stay up to date with evolving global regulations. We proactively adapt your compliance strategies and documentation to align with the latest changes, minimizing delays and avoiding non-compliance risks.
Absolutely. Visit our Contact Page or email us at enquiry@mavenprofserv.com to schedule a consultation with our regulatory experts.