QUALITY

Medica Holdings Quality Policy Is Simple:
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Our job is to anticipate and meet our customers’ requirements, comply with applicable standards and regulatory requirements, and maintain the effectiveness of our quality management system through continuous improvement in every aspect of our business.

Medica's quality system is certified to ISO 13485:2016 standards and holds a Medical Device Single Audit Program (MDSAP) certificate . MDSAP certification is paramount to manufacturer success, as it represents an internationally-recognized high standard in demonstrating regulatory compliance to users, customers, suppliers and the regulatory authorities themselves.

QUALITY MANAGEMENT SYSTEM
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ISO 13485 certified by BSI under certificate number ​FM 667023

​MDSAP (Medical Device Single Audit Program) certified by BSI under certificate number ​MDSAP 667024

US FDA (21 CR Part 820) US FDA Quality System Regulation View our Establishment Registration on the FDA website

NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY
Medica Holdings, LLC is audited every year by:

BSI Management Systems
12950 Worldgate Drive
Suite 800
Herndon VA 20170
Telephone: +1 (800) 862 4977
https://www.bsigroup.com/en-US/medical-devices/

PRODUCT CERTIFICATIONS AND APPROVALS

​CANADA
​Medical Device Licenses 
VibraPEP®


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

VibraPEP®

GLOBAL REGULATORY REPRESENTATIVES

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

AUSTRALIA
​Australian Sponsor
EMERGO AUSTRALIA
Level 20 Tower II
Darling Park 201
Sussex Street
Sydney, NSW 2000
Australia