Regulatory consulting services supporting medical device and IVD manufacturers through CE marking, FDA 510(k) clearance, and UKCA certification processes. Provides technical documentation preparation, conformity assessment, risk management, and audit support to ensure compliance with EU MDR, EU IVDR...
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.
CMG MEDDEV SL
Spain · 2 relevant products
Sotas Limited
United Kingdom · 1 relevant product
Shanghai JOYSUN Enterprise Management Technology Service Co.,Ltd.
China · 1 relevant product
59 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 94 closest product alternatives
CMG MEDDEV SL · Spain
Regulatory, clinical, and quality consulting services for medical devices, in vitro diagnostics, and software-as-a-medical-device (SaMD). Supports CE marking and FDA approval pathways, quality system implementation (ISO 15189, ISO 17025), and compliance with MDR 2017/745, IVDR 2017/746, and 21 CFR standards. Services include regulatory strategy design, requirement analysis, and market authorization across the product lifecycle.
Sotas Limited · United Kingdom
Regulatory and quality management consulting services for medical device and IVD manufacturers. Provides expertise in UK, EU, and US regulatory compliance, device registration, management systems, post-market surveillance, and in-country representation throughout the product lifecycle.
Shanghai JOYSUN Enterprise Management Technology Service Co.,Ltd. · China
Regulatory consulting services for Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) compliance in the European Union. Supports manufacturers with certification documentation, technical file preparation, notified body liaison, and post-market surveillance strategies to achieve CE marking and market authorization.
91 more product alternatives available
Create a free account to compare more product alternatives and supplier options.
© 2026 Suplivia · Home · Browse Products