International Regulatory Compliance Information

 

 

QUALITY MANAGEMENT SYSTEM


ISO 9001:2008 Quality System Certification | VIEW
ISO 13485:2003/EN ISO 13485:2012 UKAS | VIEW

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


PRODUCT CERTIFICATIONS AND APPROVALS


EUROPE - CE Marking certificates | VIEW

UNITED STATES - FDA 510(k) cleared/PMA approved devices | VIEW WEBSITE

CERTIFICATE TO FOREIGN GOVERNMENTS | VIEW


GLOBAL REGULATORY REPRESENTATIVES


Shown below are our European representatives for regulatory affairs issues and incident reporting:

Wellkang Ltd
29 Harley Street
LONDON W1G 9QR
England
United Kingdom

Wellkang.ltd.uk


NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY


Persona Medical Devices maintains ISO and CE certification and is audited every year by our registrar:

SGS North America Inc.
515 West Greens Road
Suite 775
Houston, TX 77067

us.sgs.com


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.

 

ANSI

The American National Standards Institute or ANSI (pronounced /'├Žnsi/ AN-see) 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.

 

ISO

The International Organization for Standardization (Organisation internationale de normalisation), widely known as ISO (pronounced /'a?so?/), is an international-standard-setting body composed of representatives from various national standards organizations. Founded on 23 February 1947, the organization promulgates worldwide proprietary industrial and commercial standards. It is headquartered in Geneva, Switzerland.[1] While ISO defines itself as a non-governmental organization, its ability to set standards that often become law, either through treaties or national standards, makes it more powerful than most non-governmental organizations. In practice, ISO acts as a consortium with strong links to governments.

 

CE MARK

The CE marking (also known as CE mark) is a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA). The CE marking certifies that a product has met EU consumer safety, health or environmental requirements.