Medical Device FDA Compliance Consulting

Altemir Consulting has extensive experience in medical device manufacturing quality systems and regulatory compliance, including FDA Classes I, II, and III as well as CMS reimbursement.

Areas of expertise include:

Engineering Design and New Product Introduction (NPI)

  • Multi-market Intended Use statement
  • Product testing and regulatory approvals
  • Prototyping and testing
  • 510 (k) submissions

Quality Assurance

  • Customer complaint management
  • Corrective and preventive action (CAPA) procedures
  • Non-conformance reporting and resolution
  • Qualification of key suppliers
  • Inspection planning and record keeping
  • Calibration management

Manufacturing

  • Process verification and validation
  • Lot traceability management

Quality Management System development

  • Document control management

Explore the Possibilities ...

We welcome inquiries from all businesses, small and large, that are eager to move to the next level.  Feel free to contact us to discuss your specific needs at no obligation.