Medical Devices & IVDs Regulatory Consulting Services
ABOUT US
At Maven Profcon Services LLP, we provide medical device regulatory consulting services to medical device and IVD 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
Pellentesque fermentum faucibus venenatis. Proin porttitor sem eget varius mollis. Sed vel convallis dui. Proin hendrerit neque suscipit neque iaculis.
150+ Medical Devices Quality Management System
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Cras ligula magna, convallis non purus eget, scelerisque gravida neque. Fusce sit amet sapien lorem. Mauris pharetra lorem non pretium aliquet. Etiam mollis congue neque, in tincidunt magna vulputate ac.
300+ CE Certification
Morbi lectus dui, sodales at urna at, auctor suscipit lectus. Vivamus a posuere tellus. In dapibus ac augue at aliquam. Aliquam venenatis est eget convallis commodo. Curabitur laoreet lobortis dolor, ut consectetur nunc scelerisque fringilla. Sed blandit id sem a maximus.
50+ US FDA 510(k)
Vestibulum ac turpis in quam condimentum ornare vestibulum ac eros. Morbi varius justo sed bibendum faucibus. Pellentesque nunc metus, tincidunt in accumsan sed, placerat eget justo. Nullam in dui nec mi imperdiet bibendum eu at lorem. Duis lobortis lectus vel purus egestas feugiat. Fusce et imperdiet nunc.
Why Choose Maven?
Our medical device regulatory consultancy supports manufacturers with expert advice and practical solutions to achieve regulatory compliance with confidence.
Access
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
We provide tailored solutions that prioritize client data confidentiality, ensuring timely execution and comprehensive support, including on-site visits and audit assistance.
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
At MAVEN, we are more than just medical device consultants; we are your committed partners, offering steadfast support throughout your medical device regulatory journey.
Our Regulatory Consulting Services
CE Marking Consultancy
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.
US FDA 510k
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.
UKCA Certification Consultancy
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.
CDSCO License Consultant
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.
Medical Device Quality Management System
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.
Annual Maintenance Contract
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.
Mission
Maven Profcon Services LLP aims at delivering regulatory compliance guidance at a groundbreaking proficiency and leading the way for Regulatory conscious businesses in the medical device fraternity while helping customer’s unique experiences in regulatory consultancy. Our mission is driven by the thought of exploring a local business niche and provide easy access to international practices and serve the unmet needs of all Medical device manufacturers globally.
Vision
To be a pioneering, interactive, consumer-driven, and zealously referred, leading medical device consultancy with a dynamically evolving scope of regulatory services for catering to the needs of our customers and creating a large cliental of loyal customers. Our vision is to continue exploring global trends in Regulatory services, lead by example, and justify being MAVEN, by being the connoisseurs of medical device regulatory field.
Policy
Maven Profcon Services LLP is engaged in providing the most accurate & best in time medical device consultancy with a closely knitted team. Customer commitment, Integrity, Optimum quality, confidentiality and the zest of leading are our core values. We offer an open-door policy to our employees where ideas and innovations are fostered into intangible assets and delivered to the clients. “We are a client relief organisation, who happen to offer regulatory expertise
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.
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!
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.
Clients Who Believed In Us
