ISO 13485

Certification Body for Management Systems

Germany

This scope is an annex to an accreditation certificate (D-ZM-17591-01-00) issued to Berlin Cert - Prüf- und Zertifizierstelle für Medizinprodukte GmbH, valid from 14.07.2023. The certification body meets the requirements of DIN EN ISO/IEC 17021-1:2015 for conducting conformity assessment activities. It also complies with additional legal and normative requirements, including those in relevant sectoral programs. The certification scope includes certifying management systems according to ISO 13485:2016 for medical devices, covering various regulatory areas within the EU/EWR and Germany. It specifies competence for assessing non-active and active medical devices, technical services, and other related activities. The document lists excluded product categories and services, along with abbreviations for relevant standards organizations.