EUDAMED is the European database on medical devices that supports regulatory compliance and CE marking for medical device manufacturers. This service provides access to EU regulatory information and documentation requirements for device conformity assessment and market approval.
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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3 of 87 closest product alternatives
WQS Management Consultants Inc. · United States
Regulatory consulting service guiding medical device manufacturers through EU MDR compliance, CE certification, ISO 13485 quality management systems, and technical documentation requirements for market authorization.
INTERTEK GROUP PLC · China
CE Certification service for medical devices under the Medical Device Directive (MDD) and Medical Device Regulation (MDR). Enables manufacturers to demonstrate compliance with EU regulatory requirements for market authorization. Includes conformity assessment, technical documentation review, and quality management system evaluation.
Certiquality srl · Italy
CE marking certification and regulatory compliance service for medical devices. Supports manufacturers in obtaining CE marks through assessment of supply chain qualification, legal compliance monitoring, and process control documentation. Ensures devices meet EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements.
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