Issuing Body Deutsche Akkreditierungsstelle GmbH
Issuing Body Country GERMANY
Issuing Body Website https://www.dakks.de/
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Eurofins Steripac GmbH is a specialised full-service partner for the industrial processing, sterilisation and packaging of medical devices. The company supports its customers from the development stage through comprehensive consulting and development services and offers an integrated range of services including cleaning and cleanroom assembly, development and manufacturing of validated packaging solutions including packaging validation and testing, as well as labelling and documentation in accordance with international regulatory requirements (e.g. MDR, ISO 13485 and ISO 11607).
Both in-house and coordinated sterilisation processes, together with comprehensive laboratory testing, ensure product safety and regulatory compliance across the entire value chain.
With its one-stop-shop approach, Eurofins Inpac supports manufacturers to bring safe, compliant, and market-ready medical devices to market efficiently from a single source.
Issuing Body Deutsche Akkreditierungsstelle GmbH
Issuing Body Country GERMANY
Issuing Body Website https://www.dakks.de/
Issuing Body International Accreditation Japan
Issuing Body Country JAPAN
Issuing Body Website https://www.nite.go.jp/en/iajapan/
EN ISO 13485:2016 incl. AC:2018 + A11:2021 (PDF)
Owner-Operator Number: 10042503
Establishment Number: 3009217531