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CONSULTANCY SERVICES

  • Strategic and regulatory planning

  • Auditing of Regulatory systems to ensure compliance with required regulations

  • Regulatory GAP Analysis

  • Interpretation of guidance documents and legislation

  • Assistance with device labelling requirements

  • Liaison with Regulatory Authorities

  • Provide medical device classification

  • Risk Management (ISO 14971) review

  • Regulatory and Technical review and consulting

  • Preparation and submission of registration documents for product applications

  • Regulatory and manufacturing compliance

  • Company specific training

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