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Quality System Services

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Developing a compliant, yet not overly complex, Quality System can be a challenging and ongoing effort that encompasses the entire product development process and affects how your business operates. Partnering with Orchid Design’s quality experts can help with simplifying your existing system, or developing a new system with and an efficient methodology customized around your specific business needs.

And to help ensure your continued compliance to ISO 13485, FDA QSR, and/or MDD requirements, we can provide on-site training and auditing activities.

Quality System Services

  • Development of customized Quality Systems
  • Implementation and adoption into practice
  • Authoring and technical writing of procedures and manual
  • Training of personnel - including ISO 13485, FDA QSR (GMPs), Corrective Actions
  • Auditing - including Internal, Supplier, Due Diligence
  • Continuous Improvement/Gap Assessments - including ISO 13485, FDA QSR (GMPs), Europe MDD
  • Mock FDA inspections
  • Risk management