Sadaf Rizwan

Design and Development

• Developed a QMS (Quality Management System) compliant with ISO 13485 and QSR (21 CFR 820), including document and record control, change control, non-conformance (NC) and CAPA, training processes, management review, internal audits, supplier and purchase, etc.
• Developed standard operating procedures for product development (mechanical and software) including, Design and development planning, Design development, Design reviews, Verification and validation and Software Development Lifecycle Management (SDLC).
• Successfully certified the company with ISO 13485 certification.
• Developed products ranging from Class I to Class III.
• Developed a quality-compliant culture.

Sustainment

• Set up the PMS system.
• Set up the Complaint Management and Field Correction process.

Testing Laboratory

• Developed standard operating procedures for laboratory operations.
• Set up qualification (IQ, OQ) for equipment.
• Set up Computerized System Validation (CSV) for software tools supporting quality management and testing lab.
• Set up the metrology lab for dimensional inspection.
• Set up the calibration process.