Training

(Offer structured courses with certification, if applicable)

Quality Management System (QMS) Training

  • ISO 9001 and 13485:2016
  • Quality Management Systems
  • Risk Management (ISO 14971) state of the art Multiple Decision Criteria software based on confidence interval, sensitivity analysis and FMEA principles.

Validation & Compliance Training

  • Process & Equipment Validation
  • Software Validation (CSV)
  • GMP & Regulatory Compliance

Auditing Courses

  • Internal & Supplier Auditing (ISO 13485, ISO 9001)
  • FDA & EU MDR Audit Readiness
  • CAPA & Root Cause Analysis

Lean Manufacturing & Six Sigma

  • Lean Fundamentals
  • Six Sigma (Yellow, Green, Black Belt)
  • Continuous Improvement & Waste Reduction

Regulatory & Compliance Training

  • FDA, EU MDR, GMP,
  • Post-Market Surveillance & Complaint Handling