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mdc medical device certification GmbH
Accredited by: DAkkS
mdc medical device certification GmbH certifies medical devices and related services according to ISO standards.
Ernst-Augustin-Straße 2, 12489 Berlin, Germany
Certification Scopes (4)
ISO 14001
Certification Body for Management Systems
Deutsche Akkreditierungsstelle GmbH
Germany
This scope is an attachment to an accreditation certificate issued to mdc medical device certification GmbH in Stuttgart and Berlin, valid from 12.02.2025. The certification complies with DIN EN ISO/IEC 17021-1:2015 standards for conducting conformity assessment activities. It also meets legal and normative requirements, including those in sector-specific programs. The certification covers management systems in various industries such as textiles, chemicals, machinery, healthcare, and education, in accordance with DIN EN ISO 9001:2015. The certification scope includes quality management systems and specific industry sectors listed in the document. The abbreviations used refer to organizations like DIN, EA, EN, IAF, IEC, and ISO.
ISO 13485
Certification Body for Management Systems
Deutsche Akkreditierungsstelle GmbH
Germany
This scope outlines the requirements for management systems in accordance with DIN EN ISO/IEC 17021-1, relevant for auditing and certifying organizations. It aligns with DIN EN ISO 9001 principles. The certification scope includes activities related to medical devices under DIN EN ISO 13485:2021, covering non-active medical devices, implants, wound care products, dental products, and active medical devices. It also encompasses in-vitro diagnostics, sterilization processes, products using specific materials/technologies, medical device processing, parts, and services such as training, regulatory consultations, and activities in health-related crafts. The certification is issued by the Deutsche Akkreditierungsstelle GmbH and is valid from 18.07.2022.
ISO 9001
Certification Body for Management Systems
Deutsche Akkreditierungsstelle GmbH
Germany
This scope is an attachment to an accreditation certificate issued to mdc medical device certification GmbH in Stuttgart and Berlin, valid from 12.02.2025. The certification complies with DIN EN ISO/IEC 17021-1:2015 standards for conducting conformity assessment activities. It also meets legal and normative requirements, including those in sector-specific programs. The certification covers management systems in various industries such as textiles, chemicals, machinery, healthcare, and education, in accordance with DIN EN ISO 9001:2015. The certification scope includes quality management systems and specific industry sectors listed in the document. The abbreviations used refer to organizations like DIN, EA, EN, IAF, IEC, and ISO.
ISO 45001
Certification Body for Management Systems
Deutsche Akkreditierungsstelle GmbH
Germany
This scope is an attachment to an accreditation certificate issued to mdc medical device certification GmbH in Stuttgart and Berlin, valid from 12.02.2025. The certification complies with DIN EN ISO/IEC 17021-1:2015 standards for conducting conformity assessment activities. It also meets legal and normative requirements, including those in sector-specific programs. The certification covers management systems in various industries such as textiles, chemicals, machinery, healthcare, and education, in accordance with DIN EN ISO 9001:2015. The certification scope includes quality management systems and specific industry sectors listed in the document. The abbreviations used refer to organizations like DIN, EA, EN, IAF, IEC, and ISO.
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