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us fda clearance us fda approval, fda approval, fda regulations, fda approval process, fda standards, fda clearance vs approval, us fda certification.

Arazy Group US company is Medes USA Inc., located in Seattle, Washington. Medes USA is a qualified and a recognized Regulatory Designated Agent.

Arazy Group US company is Medes USA Inc., located in Seattle, Washington. Medes USA is a qualified and a recognized Regulatory Designated Agent. We have been serving hundreds of companies worldwide since the new FDA regulation came into force on April 2002.

Global Medical Device Nomenclature is a system of internationally harmonized generic descriptors used to identify all medical products. Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.

GMDN or Global Medical Device Nomenclature is a system of internationally harmonized generic descriptors used to identify all medical products. Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.

Arazy Group offers unique line of GlobaR - Global Regulatory Hub (Trade Mark) products such as GlobaR Dossier (Trade Mark), GlobaR - One World Process (Trade Mark), GlobaR Submission Center (Trade Mark) and Universal Authorized Representative (Trade Mark).

Arazy Group help you with our expert CE Mark Consultancy services that offer verification, validation and product certification for medical devices, IVDs and equipment in Czech Republic. We also offer clinical trial monitoring and data management for you. You can gain from our numerous medical device regulatory and CE marking consulting services.

Gain medical device compliance and verification from medical device regulatory authorities in Kuwait with expert medical device consultancy services from us. Arazy Group is a global leader in medical device registration and offers a wide range of medical device regulation and clinical clearance services.

Gain medical device compliance and verification from medical device regulatory authorities in Kuwait with expert medical device consultancy services from us. Arazy Group is a global leader in medical device registration and offers a wide range of medical device regulation and clinical clearance services.

Arazy Group - Preparation of a regulatory dossier for the authorities can be cumbersome as It may contain tens of different documents, templates, reports, charts and graphics.

Arazy Group helps you with our expert CE Mark Consultancy services that offer verification, validation and product certification for medical devices, IVDs and equipment in Czech Republic. We also offer clinical trial monitoring and data management for you.

European Union (EU) Authorized Representative, USA Designated agent, China after Sales service, Central & South American registrations holding companies, Japan MAH - Marketing Authorized Holder, Product Sponsor and similar entities are the legal and regulatory bodies a medical device manufacturer needs to source, appoint, contract, pay for and renew annually in order to fully satisfy the product sales clearance requirements.

A team of professional medical device regulatory and quality experts are here to assist you with writing, reviewing or editing of an "Essential Requirements" table, a complete CE technical file, a traditional 510k or a complicated PMA file.

If you want to get your medical products registered in Argentina, you can count on the experts of Arazy Group with 15 years of experience in this domain. We provide you market clearance, clinical literature review and medical device registration in Argentina. Get in touch with us immediately to introduce and market your medical products in Argentina.

We invite you to join Arazy Group Medical Device Consultants to share your knowledge with us and get paid (well) for your contribution.

http://www.www.arazygroup.com/US-FDA-Agent - Medical device validation, FDA certification, CE Mark clearance, and regional medical device registration and global authorized representatives.