Scribd
Upload
153 views1 page

Stratec Se Iso 13485 2021 e

STRATEC SE, a German company that develops, manufactures, and distributes systems for process automation in diagnostics and biotechnology, has received ISO 13485 certification for its quality management system from 2021-12-21 to 2024-05-16. The audit conducted by mdc medical device certification GmbH found that STRATEC SE's quality management system meets all requirements of the ISO 13485 standard for medical device quality management systems.

Uploaded by

Oscar Guzman Martinez
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
153 views1 page

Stratec Se Iso 13485 2021 e

STRATEC SE, a German company that develops, manufactures, and distributes systems for process automation in diagnostics and biotechnology, has received ISO 13485 certification for its quality management system from 2021-12-21 to 2024-05-16. The audit conducted by mdc medical device certification GmbH found that STRATEC SE's quality management system meets all requirements of the ISO 13485 standard for medical device quality management systems.

Uploaded by

Oscar Guzman Martinez
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 1

mdc medical device certification GmbH

certifies that

STRATEC SE
Gewerbestraße 37
75217 Birkenfeld
Germany
for the scope

development, manufacturing and distribution of


systems for process automation in diagnostics and biotechnology

has introduced and applies a

Quality Management System

The mdc audit has proven that this quality management system
meets all requirements of the following standard

EN ISO 13485

Medical devices – Quality management systems –


Requirements for regulatory purposes

EN ISO 13485:2016 + AC:2016 - ISO 13485:2016

Valid from 2021-12-21


Valid until 2024-05-16
Registration no. D1047900023
Report no. P21-00408-222167
Stuttgart 2021-12-10

Head of Certification Body

mdc medical device certification GmbH


Kriegerstraße 6
D-70191 Stuttgart, Germany
Phone: +49-(0)711-253597-0
Fax: +49-(0)711-253597-10
Internet: http://www.mdc-ce.de For electronic publication only

You might also like