| Council of European Communities (Medical Device Directive)ProSolv maintains a comprehensive quality system in accordance with the applicable regulatory requirements under MDD 93/42/EEC, Annex V – Metrology. Under these regulations, the ProSolv product is defined as a Class I, Metrology medical device. |
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| ISO 13485ProSolv has been assessed as meeting the requirements of ISO 13485 (certificate number CA04/3201). ISO 9001 is a general standard defining quality system requirements. ISO 13485 provides particular requirements for suppliers of medical devices that are more specific than the general requirements of ISO 9001. for human error. |
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| CE Mark ProSolv holds the CE Mark. |
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ProSolv Compliance
ProSolv complies with the following bodies and standards