Medical device regulatory consulting services supporting manufacturers with CE marking, FDA 510(k) clearance, and UKCA certification. Provides technical documentation preparation, risk management, clinical evaluation, and audit support for compliance with EU MDR, EU IVDR, and UK regulatory requireme...
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.
SigmaTech Nordic
Denmark · 8 relevant products
TS Quality & Engineering SRL
Italy · 4 relevant products
BSI Group Ltd.
United Kingdom · 4 relevant products
61 more relevant manufacturers available
Get free access to all relevant manufacturers for this product.
See all manufacturers →14 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 93 closest product alternatives
SigmaTech Nordic · Denmark
Regulatory consulting service specializing in ISO 13485 certification and CE marking for medical devices. Supports diagnostic and therapeutic device manufacturers through compliance documentation, authorised representative services, and regulatory strategy across European markets. Fixed-price offerings provide cost transparency for device classification and market authorization.
TS Quality & Engineering SRL · Italy
Comprehensive certification and auditing support for medical device manufacturers seeking ISO 13485, ISO 9001, and ISO 27000 compliance. Services include quality management system development, regulatory documentation, risk management, and design control to facilitate market introduction of medical devices globally.
BSI Group Ltd. · United Kingdom
ISO 13485 certification service for medical device manufacturers ensuring compliance with international quality management standards. BSI provides accredited certification and auditing to establish safety, efficacy, and regulatory acceptance of medical devices across global markets.
90 more product alternatives available
Create a free account to compare more product alternatives and supplier options.
© 2026 Suplivia · Home · Browse Products