Regulatory consulting service supporting medical device manufacturers in obtaining European Free Sale Certificates through EU MDR compliance and CE marking assistance, including technical documentation preparation and conformity assessment support.
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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EUCEREP B.V.
Netherlands · 3 relevant products
MedNet EC-REP GmbH
Germany · 2 relevant products
CMC Medical Devices & Drugs S.L.
Spain · 5 relevant products
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EUCEREP B.V. · Netherlands
Free Sale Certificate issued by EU Authorized Representatives for non-EU medical device manufacturers seeking market access in the EU and UK. Certifies product compliance with European regulatory requirements and facilitates seamless registration with MHRA and EUDAMED systems.
MedNet EC-REP GmbH · Germany
Free Sales Certificate (FSC) documentation service for medical devices, IVDs, and regulated products entering European markets. Supports regulatory compliance and market access across EU, UK, and Switzerland under MDR, IVDR, and related frameworks. Essential for manufacturers requiring proof of legal status in non-EU origin countries.
CMC Medical Devices & Drugs S.L. · Spain
We offer Free Sale Certificate (FSC) services to support the export of your products and comply with international regulatory requirements.
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