Regulatory consulting service supporting medical device manufacturers with UKCA marking compliance, technical documentation preparation, MHRA registration, conformity assessment, and UK labeling requirements for devices and in vitro diagnostics.
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 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.
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Our experienced consulting team provides assistance in achieving and maintaining Europe CE mark certification, UKCA mark, FDA 510(k) clearances, and PMA approvals.
BSI Group Ltd. · United Kingdom
UKCA certification service for medical devices and equipment, ensuring compliance with UK regulatory standards and global conformity requirements. BSI provides notified body assessment, ISO 13485 audits, and conformity documentation to facilitate safe market placement of medical devices and in vitro diagnostics.
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