International Regulatory Compliance Information
QUALITY MANAGEMENT SYSTEM
· ISO 9001:2008 Quality System Certification | VIEW
· ISO 13485:2003 Certificate | VIEW
· ISO 13485:2003 Canadian Certificate (CMDCAS) | 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
1. CANADA- Medical device licenses | VIEW WEBSITE
2. EUROPE - CE Marking certificates | VIEW
3. UNITED STATES - FDA 510(k) cleared/PMA approved devices | VIEW WEBSITE
4. CERTIFICATE TO FOREIGN GOVERNMENTS | VIEW
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
P.O. Box 18510, NL 2502 EM
http://www.emergogroup.com/
NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY
Persona Medical Devices maintains ISO, CEand CMDCAS 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 /'ænsi?/) 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.
HEALTH CANADA
Health Canada is the department of the government of Canada with responsibility for national public health.
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.
