Registrar Corp of Hampton, Virginia at MEDICA 2017 in Düsseldorf -- COMPAMED Trade Fair
Service

Registrar Corp

144 Research Drive, 23666 Hampton, Virginia
United States of America

Telephone +1 757 2240177
Fax +1 757 2240179
info@registrarcorp.com

This company is co-exhibitor of
Messe Düsseldorf North America

Hall map

MEDICA 2017 hall map (Hall 16): stand E32-11

Fairground map

MEDICA 2017 fairground map: Hall 16

Our products

Product category: Further education and training, Education and further education institutions

MEDICAL DEVICE ESTABLISHMENT REGISTRATION AND LISTINGS

Owners or operators of places of business that are involved in the production and distribution of medical devices intended for use in the United States are required to register with FDA annually. Firms involved in manufacturing, packaging, labeling or reprocessing of devices must pay an annual fee. Many establishments that are required to register with FDA also are required to list their devices. For assistance with FDA medical device registration and listing regulations, simply click the Medical Device Certificate of Registration shown on the left.

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Product category: Further education and training, Education and further education institutions

ELECTRONIC MEDICAL DEVICE REPORTING (EMDR)

FDA now requires medical device manufacturers and importers to submit adverse event reports in electronic format. Device manufacturers and importers are required to submit adverse event reports to FDA when evidence suggests a device may have contributed to a patient death or serious injury, or when a device malfunctions and reoccurrence of the malfunction would likely contribute to death or serious injury.

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Product category: Further education and training, Education and further education institutions

MEDICAL DEVICE LABELING AND PRODUCT REVIEWS

Labeling errors are one of the leading causes of FDA detentions. Registrar Corp helps companies modify medical device labeling to comply with FDA regulations. Registrar Corp provides revised graphic files ready to be printed or edited, and a report that details the regulations, compliance guides, warning letters, import alerts, and other guidance documents from FDA.

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Product category: Further education and training, Education and further education institutions

MEDICAL DEVICE MASTER FILES (MAF)

A Medical Device Master File is a submission to FDA that may be used in support of premarket submissions to provide confidential detailed information about establishments, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more medical devices. Registrar Corp’s team of medical device regulatory experts provides guidance as to required elements, formats, and particularities of Medical Device Master File submissions.

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Product category: Further education and training, Education and further education institutions

MEDICAL DEVICE COLOR ADDITIVES AND MEDICAL DEVICE COLOR BATCH CERTIFICATION

A medical device color additive is any dye, pigment, or other substance that can impart color to a medical device. Medical device color additives are regulated by FDA.

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About us

Company details

Registrar Corp was founded in 2003 to help businesses comply with U.S. Food and Drug Administration (FDA) regulations. Since opening its headquarters in Hampton, Virginia, USA, Registrar Corp has expanded to nineteen international offices and has aided more than 30,000 companies across 160 countries. Employees include former U.S. FDA officials, scientists, and industry experts.  Registrar Corp offers FDA compliance assistance for the following industries:

  • Food and Beverages
  • Medical Devices
  • Drugs
  • Cosmetics
  • Electronics
  • Tobacco
Our Services

Registrar Corp has been a leading provider of FDA compliance assistance for more than 14 years. Our services are always provided for a low fixed-fee, never by the hour. Our multilingual Regulatory Advisors are available 24 hours a day to answer your questions via our Online Live Help. Whether you’re in need of FDA registration to labeling compliance to detention assistance, Registrar Corp is ready to assist.

Education and Outreach

The FDA regulatory landscape is constantly changing as FDA releases new rules and guidance documents.  Registrar Corp is committed to keeping industry educated on the latest FDA requirements through blogs, trade shows, seminars, webinars, and various other outreach. Our Regulatory Specialists review every regulation thoroughly and communicate with FDA regularly to ensure full understanding of the Agency’s expectations of industry.

  • Subscribe to our blog
  • Meet us at an upcoming trade show
  • Attend a seminar or webinar
Software Solutions

Registrar Corp provides a variety of software solutions to aid in compliance with FDA requirements.

  • FDA Compliance Monitor – A tool to help food facilities and importers evaluate their suppliers’ FDA compliance and approve suppliers, as required under FSMA.
  • Prior Notice Express – Prior Notice must be submitted to FDA for each food, beverage, or supplement shipment to the USA. Our Express service makes submitting Prior Notice quick and easy.
  • FSMA Wizard – A free tool to help food facilities, importers, and farms determine their possible requirements under FDA’s Food Safety Modernization Act (FSMA).
  • FCE Wizard – Determine whether products may be subject to FDA FCE-SID requirements.
  • SID Verifier – Verify whether SIDs are currently on file in FDA’s database.
Customs Brokers

Registrar Corp values its relationships with the Customs community. We are a member of the National Customs Brokers and Forwarders Association of America (NCBFAA), among others, and offer a variety of complimentary services to Brokers, including:

  • Advice for all FDA questions, including product codes, AofC Codes, and DUNS numbers.
  • Detention assistance (we may charge the shipper to perform services to bring products into compliance, like a label revision).
  • Educational webinars for your clients on the FDA regulations that matter to them most.
Five Star Service

Registrar Corp prides itself on professional and reliable service.  Don’t take it from us – click here to read our customer reviews.

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