ISO13485:2016 Certification
Expert guidance for medical device quality management system implementation and certification to meet regulatory requirements and ensure patient safety.
Understanding ISO13485:2016
What is ISO13485:2016?
ISO13485:2016 is the internationally recognized quality management standard specifically designed for organizations involved in the design, production, installation, and servicing of medical devices and related services. It provides a comprehensive framework for establishing and maintaining effective quality management systems that consistently meet customer and regulatory requirements.
While based on the structure of ISO9001, ISO13485 places greater emphasis on regulatory compliance, risk management, and maintaining effective processes specifically for medical devices. It is designed to be used by organizations throughout the medical device supply chain, from component manufacturers to finished device producers, distributors, and service providers.
ISO13485 certification demonstrates your commitment to quality and safety in the medical device industry and is often a prerequisite for market access in many countries. It also serves as a foundation for meeting the quality system requirements of various regulatory frameworks, including the EU Medical Device Regulation (MDR), the US FDA’s Quality System Regulation (21 CFR Part 820), and other international regulatory requirements.
At Falcon Quality, we specialize in helping medical device organizations implement practical, value-adding ISO13485 systems that satisfy certification requirements while supporting regulatory compliance and driving real business improvement.
Benefits of ISO13485 Certification
How ISO13485 certification can transform your medical device organization.
Global Market Access
Facilitate regulatory approvals and market access in multiple countries through a recognized quality management system.
Enhanced Patient Safety
Implement robust processes for risk management and product safety, reducing risks and ensuring the highest standards of patient safety.
Regulatory Compliance
Establish a foundation for meeting various regulatory requirements, including EU MDR, US FDA QSR, and other international regulations.
Operational Excellence
Improve process efficiency, reduce waste, and enhance productivity through systematic process management and continuous improvement.
Risk Management
Implement comprehensive risk management throughout the product lifecycle, from design to post-market surveillance.
Supply Chain Integration
Establish effective controls for suppliers and outsourced processes, ensuring quality throughout the supply chain.
Key Differences Between ISO13485 and ISO9001
Understanding the medical device-specific requirements that extend beyond ISO9001.
Regulatory Focus
- ISO13485 emphasizes meeting regulatory requirements and maintaining regulatory compliance
- Specific requirements for documentation to support regulatory submissions
- Focus on maintaining the effectiveness of processes rather than continual improvement
- Requirements for reporting to regulatory authorities
Risk Management
- Comprehensive risk management throughout the product lifecycle
- Application of risk-based approaches to control processes
- Verification and validation activities based on risk
- Risk management in design and development, production, and post-market activities
Documentation Requirements
- More extensive documentation requirements than ISO9001
- Specific requirements for device master records and device history records
- Detailed documentation for design and development activities
- Specific requirements for technical files and design dossiers
Sterile Medical Devices
- Specific requirements for validation of sterilization processes
- Controls for contamination and cleanliness
- Maintenance of sterile barrier systems
- Validation of sterile packaging processes
Infrastructure and Work Environment
- Specific requirements for infrastructure to prevent product mix-up
- Controls for contamination of product
- Requirements for health, cleanliness, and clothing of personnel
- Environmental controls for product quality
FAQ's
Frequently Asked Questions About ISO13485
Common questions about ISO13485 certification and implementation.
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