ISO 13485

Certification Body for Management Systems

Germany

This scope is an annex to an accreditation certificate issued by the German Accreditation Body, valid from 03.07.2023, and issued on 04.12.2024 to ECM Certification Company for Medical Devices in Europe. It confirms compliance with DIN EN ISO/IEC 17021-1:2015 for conducting conformity assessment activities. The certification also meets additional legal and normative requirements, including those in sector-specific programs. It aligns with the principles of DIN EN ISO 9001 and includes additional requirements for certifying bodies operating in the field of quality management systems for medical devices according to ISO 13485:2016. The certification scope covers various non-active medical devices, excluding certain categories like contraceptives and specific implants. It also includes sterilization methods, products containing certain substances/technologies, and parts/services related to medical devices. The technical areas covered by the certification program include organizations involved in different stages of a medical device's lifecycle, healthcare facilities, and custom manufacturers. The document provides explanations for various abbreviations used, including DIN (German Institute for Standardization), EN (European Standard), EU (European Union), EWR (European Economic Area), IEC (International Electrotechnical Commission), and ISO (International Organization for Standardization).