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Regulatory Compliance

Farm is an ISO 13485 certified and FDA compliant product development firm offering comprehensive development services through feasibility and design controls.

Farm complies with the process controls required for Specification Developers under the Quality System Regulations of Section 21 of the Code of Federal Regulations Part 820 and International Standards Organization 13485/2003. As a Specification Developer, Farm creates elements for Design History Files and Device Master Records following our clients’ or Farm’s own quality management system standard operating procedures.

Farm works closely with our clients to establish design and development plans to meet our customer’s requirements for quality planning and regulatory compliance. Farm works diligently yet efficiently through feasibility documenting key decisions and down selection criteria while controlling revisions to inputs, risk analyses, and development plans. Once under controls and based on the contractual agreement, Farm supports customers in the production of manufacturing equivalent units for verification and validation. Farm’s rigorous yet optimized feasibility and controlled development programs rely on close customer engagement from inputs development to transfer. We invite you to take a tour of our facilities and learn more about our regulatory compliance services.

Regulatory Compliance ServicesTUV Certification

Farm generates:

  • Design plans
  • Design inputs
  • Risk analyses
  • Formal design reviews
  • Drawings and specifications
  • Verification and validation
  • Work instructions
  • Labeling
  • Change control
  • Design transfer