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ISO 13485 and MDD certification consulting and assistanceWe provide assistance, consulting and training for ISO 13485 and MDD certificationCertification to ISO 13485:2003: Certification to ISO 13485 sometimes also called registration to ISO 13485 refers to the process of being successfully audited by a third party organization called a notified body. The Notified body issues a certificate to ISO 13485:2003 covering the activities and facilities successfully audited, and can meet the Quality System compliance requirement of the European Medical Device Directive (MDD) or the In Vitro Device Directive (IVD). ISO 13485 is a quality management standard and sets requirements for all aspects of the operation of an organization (Sales, Purchasing, Manufacturing, design, service delivery, etc...). Its main focus is on insuring the safety and efficacy of the medical device. ISO 13485 does not address or have requirements related to accounting, finance and personnel. Human resources such as hiring and training are covered . The purpose of this standard is to ensure that an organization will consistently provide products or services that meet customer and applicable regulatory requirements, and will enhance customer satisfaction by being effective its operation and will continually improving it. ISO 13485:2003 Certification consulting: SATISFACTION GUARANTEED If your company wishes for Certification Xpert to drive the implementation to comply and be certified with ISO 13485:2008, we offer an implementation service that follows a 6-step methodology: Gap assessment, quality management system upgrade, training, internal audit, management review and certification audit. We provide and generate all the required documentation to meet the requirements of the standard. The implementation of ISO 13485 involves improvement and simplification of your operation and take full advantage of the benefits of the standard. It is also usually parallel-processed with preparing the submittals for the medical device CE certification (technical file) We guarantee your certification provided you follow our recommendation in a timely manner. |
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