International Regulatory Compliance Information

 

 

QUALITY MANAGEMENT SYSTEM

 

ISO 13485 quality system certification (PDF format)
ISO 13485:2003 certificate

US FDA Good Manufacturing Practice (GMP)
We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations.

PRODUCT CERTIFICATIONS AND APPROVALS

 

CANADA- Medical device licenses (Links to Health Canada website)

EUROPE - CE Marking certificates (PDF format)

EUROPE - Declarations of Conformity (PDF format)

UNITED STATES - FDA 510(k) cleared/PMA approved devices (Links to US FDA database device listing)


GLOBAL REGULATORY REPRESENTATIVES

 

Shown below are our in-country representatives for regulatory affairs issues and incident reporting.

EUROPE - Authorized Representative
Emergo Europe, The Hague, NETHERLANDS
Telephone: +31.70.345.8570
http://www.EmergoGroup.com

 

NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY

 

ABC Medical Devices maintains ISO 13485:2003 certification and is audited every year by:

AAA Auditing Services
Anytown, USA
Telephone: +1.555.555.1234
Website link


THE BREAKDOWN

 

FDA

The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from pet turtles to semen donations for assisted reproductive medicine techniques.

 

ANSI

The American National Standards Institute or ANSI (pronounced /'├Žnsi?/) is a private non-profit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States. The organization also coordinates U.S. standards with international standards so that American products can be used worldwide. For example, standards make sure that people who own cameras can find the film they need for that camera anywhere around the globe. ANSI accredits standards that are developed by representatives of standards developing organizations, government agencies, consumer groups, companies, and others. These standards ensure that the characteristics and performance of products are consistent, that people use the same definitions and terms, and that products are tested the same way. ANSI also accredits organizations that carry out product or personnel certification in accordance with requirements defined in international standards.