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ISO 9000, EN46000 and ISO 13485 The International Organization for Standards (ISO) has developed a series of international Quality Assurance standards and quality systems for the medical device industry. In order to market a medical product to the European Community, a CE mark is required that compels medical companies to be ISO 9000 and EN 46000 compliant or ISO 13485. Regulatory Specialists, Inc. has assisted a large number medical companies to become compliant with ISO and EN regulations. Our level of assistance ranges from simple client audits to complete arrangement of ISO and EN Quality Systems within that client's business framework. Services
CE Mark Medical devices and diagnostics to be marketed in Europe are now required to have conformance to the Medical Device Directives (MDD) or Invitro Diagnostics Directives (IVDD) and to be CE marked. Regulatory Specialists, Inc. can assist with both the MDD, and IVDD classifications testing requirements, as well as obtaining CE certification through development of a Technical File. Services
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