At Maven Profcon Services LLP, we provide medical device regulatory consulting services to medical device and IVDs manufacturers Since 2016, we have supported 350+ clients — from startups to multinational companies — with practical regulatory strategies, personalized support, and global regulatory expertise.
Our team helps manufacturers achieve regulatory approvals and maintain ongoing regulatory compliance across major international markets, ensuring smoother market entry and long-term regulatory confidence.
45+
Annual Maintenance
Clients
150+
Medical Devices Quality Management System
300+
CE Certification
50+
US FDA 510(k)
Our medical device regulatory consultants provide regulatory consulting services to medical device and in vitro diagnostic (IVD) manufacturers seeking CE marking for their devices. Our comprehensive medical device regulatory consultancy supports manufacturers throughout the entire conformity assessment process for CE certification by assisting with the preparation of technical documentation such as clinical evaluation, post-market surveillance, risk management, GSPR, and more, as well as mock audits and on-site audit support. Our goal is to help manufacturers meet EU MDR and EU IVDR regulatory requirements and obtain CE certification for their medical devices and IVDs.
We can guide you through the entire US FDA 510(k) approval process for your medical and in vitro diagnostic devices. We provide support in identifying the exact product code for your device as per US FDA requirements, selecting an appropriate predicate device to establish substantial equivalence, determining performance requirements for your device, and assisting with eSTAR submission. As a medical device regulatory consultancy company, our role is to help manufacturers efficiently meet US FDA regulatory requirements and achieve successful 510(k) clearance for their medical devices and IVDs.
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 & IVD manufacturers to simplify the regulatory certification process, ensuring smooth and efficient market entry into the UK.
As leading medical device regulatory consultants, we provide expert regulatory services to help medical device & IVD manufacturers meet Indian 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 a 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.
MD-QMS is the foundation that medical device manufacturers follow to comply with global regulatory requirements. A strong ISO 13485 implementation within the organization facilitates global approvals. Our regulatory consulting services for MD-QMS include document preparation, such as the quality manual, procedures, and formats in line with ISO 13485 requirements; implementation of these documents within the organization; conducting internal audits; and support during the certification audit. Our team can also integrate MDSAP and 21 CFR requirements into your existing MD-QMS documentation.
Our Annual Maintenance Contract services support medical device and IVD manufacturers with ongoing regulatory compliance consulting after certification. We manage quality management systems, internal audits, management reviews, audit preparation, and post market surveillance. With regular reviews, on site support, and continuous regulatory updates, we help companies stay audit ready, close non conformities on time, and maintain certifications smoothly across global markets.
Our medical device regulatory consultancy supports manufacturers with expert advice and practical solutions to achieve regulatory compliance with confidence.
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 medical device consultants; we are your committed partners, offering steadfast support throughout your medical device regulatory journey.
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.
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