CE Regulatory Consultant

SQM provides strategic and operational support to companies that purchase products from external suppliers and take on the role of manufacturers responsible for CE marking, ensuring compliance with current European regulations.

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1.

Technical Documentation Preparation

We prepare and verify all documentation required by regulations to demonstrate product compliance.

  • $

    Preparation of technical files compliant with required specifications.
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    Development of CE Declaration of Conformity.
  • $

    Verification and validation of artworks, product documentation, and labeling.

2.

Regulatory Analysis and Compliance Strategy

We define the regulatory scope of the product and the most efficient path to obtain CE marking, anticipating risks and timelines.

  • $

    Assessment of applicable regulatory requirements based on product category.
  • $

    Definition of the most appropriate CE certification strategy.
  • $

    Identification of relevant European directives and regulations.

3.

Certification Procedure Management

We coordinate testing and communications with notified bodies and laboratories, ensuring tests and verifications in line with applicable standards.

  • $

    Interface with notified bodies for certification.
  • $

    Support in conducting compliance testing.
  • $

    Coordination of laboratory testing and safety analysis.

4.

Batch Audits and Inspections

We monitor processes and products to maintain compliance over time, reducing non-conformities and rework before market placement.

  • $

    Execution of inspections
  • $

    Conducting internal audits to ensure continuous compliance.
  • $

    Staff training on regulations and regulatory requirements.

5.

Regulatory Monitoring and Updates

We monitor processes and products to maintain compliance over time, reducing non-conformities and rework before market placement.

  • $

    Constant updates on regulatory changes at European level.
  • $

    Assessment of the impact of new regulations on already certified products.
  • $

    Implementation of any necessary corrective actions.

Trust a Regulatory Consultant

Relying on a regulatory consultant like SQM allows companies to operate safely in the complex European regulatory landscape, reducing the risk of non-compliance disputes and accelerating market entry for their products.

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