Regulatory consulting services for CE marking of medical device software (SaMD) and in vitro diagnostics. Provides technical documentation preparation, clinical evaluation, risk management, and conformity assessment support to meet EU MDR requirements.
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.
CMG MEDDEV SL · Spain
Regulatory consultancy services for medical devices, in vitro diagnostics, software as a medical device (SaMD), and AI-based medical technologies. Supports CE marking and FDA approval pathways, quality system implementation, and clinical testing compliance with MDR 2017/745, IVDR 2017/746, and 21 CFR standards.
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.
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