QUALITY
Medica Holdings Quality Policy Is Simple:
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.
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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PRODUCT CERTIFICATIONS AND APPROVALSCANADA
Medical Device Licenses VibraPEP® UNITED STATES FDA 510(k) cleared/PMA approved devices (Links to US FDA database device listing) VibraPEP® | MM Atomizer™ |
GLOBAL REGULATORY REPRESENTATIVESShown 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 |