Specialized regulatory consulting for in vitro diagnostic device manufacturers seeking CE marking, US FDA 510(k), UKCA, and Indian regulatory approvals with comprehensive technical documentation support.
Manufactured by
Maven Profcon Services LLP
Ahmedabad, India
We are a medical and IVD device regulatory consultancy that was established in 2016 and ever since we have been offering a wide array of services to the medical device fraternity to meet their regulatory needs. Our services include both holistic and customized solutions where we provide clients with end-to-end support for their certification requirements and also offer customized support if they are looking for specific documentation/services support instead of an entire submission. Our services include but are not limited to - CE - USFDA - UKCA - ISO 13485 - MDSAP - 21 CFR Part 820 - Clinical Trials - Country Registrations - Authorised Representative services (EC REP, UKRP, US agent, Swiss Rep) - UDI support - Annual Maintenance Services - Premium Organisational Maintenance Services - Clinical Evaluation writing and many more We have assisted more than 350 manufacturers with various certification requirements and our clients are based all around the globe.
✦ Product-Specific Coverage
Based on AI-matched alternatives related to this product across Suplivia's medical sourcing network.
Generated for this product
AI-matched supplier coverage based on related product alternatives.
DCN Diagnostics
United States · 3 relevant products
Sclavo Diagnostics International S.p.A.
Italy · 1 relevant product
CMC Medical Devices & Drugs S.L.
Spain · 2 relevant products
54 more relevant manufacturers available
Get free access to all relevant manufacturers for this product.
See all manufacturers →11 more sourcing countries available
Get free access to all sourcing countries identified for this product.
See all countries →See the full supplier coverage for this product
Get free access to all relevant manufacturers, sourcing countries, and product alternatives.
✓ Free for medical industry professionals.
from other manufacturers
from other manufacturers
3 of 78 closest product alternatives
DCN Diagnostics · United States
Comprehensive consulting for in-vitro diagnostic device development from concept through commercialization, providing strategic guidance and technical expertise.
Sclavo Diagnostics International S.p.A. · Italy
Expert guidance on IVDR, ISO 13485, and other regulatory requirements for in vitro diagnostics. Ensures products meet international standards and quality expectations.
CMC Medical Devices & Drugs S.L. · Spain
Regulatory consulting service for medical device and in vitro diagnostic (IVD) compliance across multiple jurisdictions. Provides market access strategy, country representation, and technical guidance to manufacturers navigating IVDR 2017/746 and harmonized standards requirements globally.
75 more product alternatives available
Create a free account to compare more product alternatives and supplier options.
© 2026 Suplivia · Home · Browse Products