KEY COMPETENCE AND EXPERIENCE:
EU MDR 2017/745
EU MDD 93/42/EEC
ISO 13485
ISO 14971, ISO/TR 24971
U.S. Medical Device Regulation
Canadian CMDR (SOR/98-282)
KEY CONSULTANCY SERVICES:
Audit and Assessment
Risk Management
Complaint Handling and Recalls
CAPA and Root Cause Analysis
Supplier Management
PLM, CRM, and ERP Software Implementation and Integration
Software Tool Validation
Document Control
SOP Writing and Lifecycle Management
Change Impacts Analysis and Change Management
Quality Culture
Training and Education
Agile Methodology
Organizational Behaviour and Institutional Decision Making
Management and Leadership
Metrics, KPI, and Objectives & Key Results (OKR)