The medical device industry makes a diverse range of products from surgical masks to implants and grafts to tubes, pumps, injectors, and syringes used in outpatient and inpatient procedures. Like prescription drugs, medical devices are regulated by the Food and Drug Administration (FDA), but under their Center for Devices and Radiological Health (CDRH).

Labtopia has decades of experience in the Medical Device industry as it was founded as a quality consulting firm specializing in ISO 13485 and FDA regulations. Our experts have real-world industry experience which we bring to all of our clients as best practice solutions.  Labtopia works with technical teams to implement operational enhancements in business processes.  Labtopia’s medical device consultation services include assistance with compliance and navigating FDA requirements and guidelines including:

  • 510(k) applications
  • Pre-Market Approval Applications
  • FDA Establishment Registration
  • Device Registration and Classification
  • Label Guidance
  • Adverse Events and Medical Device Reporting (eMDR)
  • Recalls
  • FDA Audits
  • Third-Party Audits
  • FDA Warning Letters and Corrective Actions

Labtopia’s medical device quality system services include:

  • Design and Implement ISO 13485 Quality System
  • Implementation of FDA Good Manufacturing Practices (GMPs)
  • Gap Assessments
  • Internal Audits
  • Management Review Assistance
  • Supplier Audits
  • Procedure Writing
  • Process Mapping/Process Improvement
  • Quality System Training
  • Corrective and Preventive Action Management
  • Systems Validation
  • Interim and Part-Time Quality Assurance Support