Package validation

ISO 11607 is the principal guidance document for validating terminally sterilized medical device packaging systems. Packaging must comply with ISO 11607 in order to satisfy European regulations and obtain a CE Mark.  ISO 11607 is also an FDA Recognized Consensus Standard.  Fulfilling the requirements within ISO 11607 ensures that a medical device packaging system allows sterilization, provides physical protection and maintains sterility up to the point of use. Test reports are traceable and verifiable through our sister company IETQAN web site. This way you will be able to share the report with regulatory agencies and clients with high credibility level. 

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A European Authorised Representative (E.A.R.) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives/Regualtions

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