Services

Drop-in Quality & Compliance Leadership

QMS Development & Implementation

  • quality manual
  • environmental monitoring
  • sterilization validation (e-beam & gamma)
  • packaging validation (performance & stability)
  • biocompatibility
  • equipment maintenance and calibration
  • complaint handling
  • adverse event/incident reporting (MDR, MDV)
  • recall/field safety corrective action (FSCA)
  • design verification and validation
  • test method validation
  • process validation (IQ, OQ, PQ)
  • internal audits
  • risk management
  • corrective action/preventive action (CAPA)

ISO 13485 Certification Audit Support

QMS Review & Gap Assessment

Complaint Handling (MDR/MDV) Assistance

FDA Request for Additional Information (MDR) Support

FDA Form 483 Response & Follow-up Assistance

Recall/Field Safety Corrective Action (FSCA) Support

IEC 60601-1 Medical Electrical Equipment Assistance

Medical Device Single Audit Program (MDSAP) Preparation

QMS Training & Remediation Assistance