About Us

With over 25 years of experience and expertise in Medical device manufacturing including ELISA, CLIA, Rapid Tests, Serology, IFA and more, we provide full-service quality consulting and support to our clients with QMS documentation, QMS implementation, Training and Gap analysis and certification to be in compliance with FDA regulations, ISO and EC Directives requirements.

We will develop regulatory strategies tailored to our clients’ business and helping them achieving their goals reaching the global markets and expanding their business.

We assist with all types of facility registration with different regulatory agencies and prepare and submit application for all kind of required certificates effectively and quickly.

We regularly work with FDA, Notified Bodies, Competent Authorities, European Authorized Representatives and other global regulatory authorities.

Consulting Expertise

ISO 13485-2016 Quality System Management and Certification

ISO 13485 Implementation and certification for a quality management system specific to the medical devices industry.

ISO 9001-2012 Quality System Management and Certification

QMS implementation and certification

FDA Device Classification

Product Review and Classification

FDA Authorized USA Agent for foreign manufacturers

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment. We will act as your US agent and will do all registration process, device listing and communications with FDA on your behalf.

FDA Quality System Management

Implementation and certification for a quality management system specific to the compliance with FDA regulation.

FDA Device listing

FDA Initial Establishment Registration

FDA Establishment Annual Registration

FDA CFG certificate (Certificate of Foreign Government)

FDA 801 Export certificate

Classifying medical devices and submission and obtaining 801 Certificate

FDA 802 Export certificate

Classifying medical devices and submission and obtaining 802 Certificate

FDA CBER Export Certificate

Classifying medical devices and submission and obtaining CBER Certificate

FDA Import for Export compliance system (ACE)

Preparing and set up IFE system for smooth Import for Export

FDA UDI (Unique device Identification) compliance

FDA 483 Inspection Observations Response

Preparing Root Cause Analysis and Corrective Action Preventive Action (CAPA) and response to FDA-483 letters

State of California Food and Drug Branch (FDB) license registration

Applying, submission and obtaining Manufacturing License

Health Canada License

Applying, submission and obtaining Health Canada license to market products in Canada

Self-certified CE marking (Low Risk)

Preparing complete CE technical files for self-certified IVD devices to market in European countries

Self-testing/OTC CE marking

Submission and obtaining self-Testing (OTC) CE certificate for IVD devices to market in European countries

High Risk CE marking

Submission and obtaining High Risk (Device A and B listed in EC Directives) CE mark for IVD devices to market in European countries

Updating CE marking Annual files

Updating technical files for IVD devices to renew annual CE marked products

Europe Free Sales certificates

Submission and obtaining Free Sales Certificates for IVD devices

Preparing registration documents

Preparing technical files required for registration of products in different countries

Preparing and reviewing documents for ISO Registrar Audits

Preparing and reviewing documents for FDA Audits


CEpartner4U

Regulatory Solutions, Inc is CEpartner4U US Representative

CEpartner4U
Esdoornlaan 13
3951 DB Maarn
The Netherlands
Office: +31.343.442.524
Cell: +31.6.516.536.26
www.cepartner4u.com
office@cepartner4u.com

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