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This training provides you with an overview of the purpose and requirements of the revised ISO 13485:2016 standard for medical devices quality management Because the regulatory requirements of the MDD 93/42 and the German Medical Device Law permit exclusions of design and development controls (see 7.3), this can ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) Certificate DIN EN ISO 13485 as PDF DIN EN ISO 13485: Deutsch / English. We have not slackened off in our environmental offensive either and a long standingOur ISO 13485 PDF free downloads and resources help clients understand how to align your organisation with the requirements of the standard, and could work pdf 391 KB. Download. Medical Devices Certification. Deloro Wear Solutions GmbH, ISO 13485 gueltig bis 15.11.2021, deutsch. pdf 452 KB. PDF – Medicoat AG – ISO 13485:MP2016-2021-02-13-deutsch; PDF – Medicoat AG – ISO 13485:MP2016 2021-02-13 englisch IQNet; PDF – Medicoat AG – ISO DIN EN ISO 13485 - 2016-08 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO