Quality Assurance Management Certificate

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In respect of: The design and manufacture of single use instruments, catheters and access devices for intravascular and non-vascular applications, biopsy devices, fluid administration and pressure monitoring devices on the basis of our examination of the quality assurance system under the requirements of Council Directive 93/42/EEC, Annex II excluding section 4. For and on behalf of BSI, a Notified Body for the above Directive (Notified Body , alidity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body.. EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4 List of Significant Subcontractors Recognised as being involved in services relating to the product covered by: Certificate No: CE Date: 19 Feb 2014 Issued To: Argon Medical Devices, Inc.. 84048 Mexico Control of Sterilization Manufacture Packaging


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