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