Regulatory Quality Assurance - Regulatory Compliance

By: Real Regulatory  05/12/2011
Keywords: Risk Management, quality assurance, Regulatory Compliance

Prepare early:

Pharmaceutical Industry:

Medical Devices:

  • Working with clients to plan, develop and implement an ISO 13485:2003 or ISO 9001:2008 quality management system (or parts thereof) including CMDCAS
  • Conducting audits on behalf of client companies (supplier audits / internal audits)
  • Conducting pre-inspection audits to assess readiness for quality management system certification/registration
  • Creating /updating specific quality management system / regulatory processes, as required (for example, risk management as per ISO 14971, vigilance and/or adverse event reporting, etc.)
  • Languages for auditing: English and German

Keywords: quality assurance, Regulatory Compliance, Risk Management

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