Quality and certifications
Over the years, Medica has developed and maintained its own Quality Management System (QMS). This is the tool for all the companies in the Group and for the men and women who make up the Group, to work effectively on the basis of common practices, intentions and objectives.
The continuous improvement of the Quality Management System (QMS) has allowed us to increase its effectiveness, always operating in full compliance with regulatory requirements and offering our customers excellent products, processes, services and business relationships.
Quality Management System Certifications:
| DownloadPDF | PC 3686 GROUP ISO 9001 |
| DownloadPDF | PC 3686 GROUP ISO 13485 |
Medica Group's QMS also complies with the:
CODE OF FEDERAL REGULATIONS - TITLE 21- PART 820: QUALITY SYSTEM REGULATION
Product Certifications:
| DownloadPDF | Regulation (EU) 2017/745 - Certificate EC MDR 00048-A |
For the purposes of Regulation (EU) 2023/607, the EC type-Certification of certain medical devices not yet listed on the MDR 00048-A EC Certificate is still valid, based on:
| DownloadPDF | Directive 93/42 - Certificate EC MDD MED23010A |
| DownloadPDF | MDR00048 MEDICA CONFIRMATION LETTER
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