Medica Holdings, LLC
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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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MDSAP (ISO 13485:2016) certified by SGS under certificate number ​US22/00000011

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 by:

SGS United Kingdom Ltd
Rossmore Business Park
Ellesmere Port
Cheshire, CH65 3EN, UK
Telephone: +44 (0)151 350-6666
https://www.sgs.pl/en/vr/certified-client-directory

PRODUCT CERTIFICATIONS AND APPROVALS

​CANADA
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Medical Device Licenses 
VibraPEP®


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

VibraPEP®
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