ISO 13485:2016 - Quality Management System - Medical Devices
ISO 13485:2016 specifies requirements for a quality management system for medical devices, ensuring safety and regulatory compliance throughout the product lifecycle.
Overview
ISO 13485:2016 is the international standard for medical device quality management systems. It is essential for manufacturers, distributors, and service providers in the medical device industry. Excellency BD helps organizations in Bangladesh achieve compliance with regulatory requirements including FDA, CE marking, and local authority expectations through structured implementation and certification support.
Core Principles
Regulatory Compliance: Alignment with medical device regulations and global market requirements.
Risk Management: ISO 14971 integration for product safety throughout the lifecycle.
Traceability: Full traceability of products, components, and processes.
Document Control: Rigorous control of quality documentation and records.
Process Validation: Validation of production and service delivery processes.
Key Benefits
Certification Process
Gap Analysis
We assess your current processes against standard requirements and identify gaps.
Documentation
Development of policies, procedures, and records aligned with the standard.
Implementation
Roll-out of the management system across your organization with expert guidance.
Internal Audit
Conduct internal audits to verify readiness and address non-conformities.
Certification Audit
Support through stage 1 and stage 2 certification audits with the certification body.
Certification & Beyond
Receive your certificate and ongoing support for surveillance audits.
Related Services
Why Excellency BD?
- ✓ Expert ISO consultants
- ✓ End-to-end support
- ✓ Affordable pricing
- ✓ Timely certification