Medical Devices & IVDs Regulatory Consulting Services
Our Services
CE CERTIFICATION CONSULTANCY FOR MEDICAL DEVICE
CDSCO APPROVALS FOR MEDICAL DEVICES
US FDA 510(k) APPROVAL CONSULTANCY
UKCA CERTIFICATION REGULATORY CONSULTANCY
OTHER REGULATORY CONSULTANCY SERVICES
Get a Quote For Your Project
About Us
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.
Annual Maintenance Clients
Medical Devices Quality Management System
CE Certifications
US FDA 510(k)
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.
Why Choose Us
Our medical device regulatory consultancy supports manufacturers with expert advice and practical solutions to achieve regulatory compliance with confidence.
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
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 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.
Call For Enquiry:
+91-7490017774
Companies Who Trusted Us
