Regulatory consulting services supporting medical device and IVD manufacturers through CE marking, US FDA 510(k) clearance, and UKCA certification. Services include technical documentation preparation, conformity assessment, clinical evaluation, risk management, and audit support to ensure complianc...
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.
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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.
Prolinx GmbH · Germany
EU regulatory compliance and market access services for medical device manufacturers, including authorized representative designation, MDR/IVDR registration, and CE marking documentation to facilitate entry into European markets.
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.
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