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Quality and Regulatory Consulting Services
that are
Individualized to Product and Organizational goals

Quality System Development

  • QMS planning

  • Improvement of products and processes

  • Performance evaluation

  • Work process flow documentation

  • ISO9001 Certification

Regulatory Strategy Development

  • Determining applicable regulatory requirements

  • Guiding product development and validation

  • Interfacing with certification laboratories

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Functional Safety Solutions

  • Identifying the product requirements and standards

  • Planning the FuSa realization process

  • Guiding product development, verification and validation

  • Interfacing with certification laboratories

  • Planning verification, validation and FuSa certification

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