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Sep 28 2017 · Hello members I am working in a erw steel tube making company as a QC manager Now when I make a mill test certificate at the enclosure I use to mention that the certificate is as per EN1020431B standard as the said standard is referring our process so mentioning the said standard directly in mtc is ok or shall i have to ask an organisation to have this certificate firstthen only i

FDA and CE approval When it comes to maintaining the conformity with both US FDA’s regulations and the European Union’s EU Medical Device Directive MDD which will soon transition to the new Medical Device Regulation MDR Medical Device companies undoubtedly encounter some difficulties

FDA approval means that the device is approved for use in all parts of the world while the CE mark has restrictions sometimes even within the EU As one medical device company founder says of the CE marking “there is no guarantee that the device will be widely accepted by physicians or reimbursable by the government in each European

General InVitro Diagnostic Medical Device Directive 9879EC was established on December 7th 1998 Three years and six months of grace were given from June 2000 and the directive became effective on December 7th 2003 to all IVD devices until now In Vitro Diagnostic medical devices or IVD39s are critical medical devices that can be used to help the patie

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ISO 90012008 and ISO 90012015 provide industrywide certification standards for a company’s quality management system QMS Certification requires thirdparty endorsement from an accredited registrar The following Nucor divisions are certified

BSI is a Notified Body for the Pressure Equipment Directive and a leading provider of testing and certification solutions We offer a complete compliance service on products including design appraisal from fire extinguishers to major industrial installations

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ISO 45001 OHSAS 18001 Occupational health and safety CE marking allows you to legally market and distribute your product within the European Market and declares that your product complies with all applicable European Directives and Regulations

ISO 13485 is a QMS Quality Management Standard specifically targeted for the manufacture of Medical devices An ISO13485 certified product can be qualified and certified for CE certification

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