ISO13485:2016 Certification
Expert guidance for medical device quality management system implementation and certification to meet regulatory requirements and ensure patient safety.
Understanding ISO 13485:2016
The medical device industry’s quality management standard.
What is ISO 13485:2016?
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.
How does ISO13485 relate to FDA and EU regulatory requirements?
ISO13485 serves as a foundation for meeting various regulatory requirements, but it’s important to understand that certification alone doesn’t guarantee regulatory compliance. For FDA compliance, ISO13485 covers many of the requirements in 21 CFR Part 820 (Quality System Regulation), but there are differences that need to be addressed. For EU market access, ISO13485 certification is often a key element in demonstrating conformity with the quality management system requirements of the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). However, these regulations include additional requirements beyond ISO13485. Our approach includes a gap analysis against both ISO13485 and applicable regulatory requirements to ensure your quality management system supports your regulatory strategy.
How quickly will I receive a response?
We typically respond to all inquiries within 1 business day. For complex requests or detailed quote requests, we may need additional time to prepare a comprehensive response, but we’ll always acknowledge receipt of your message promptly and provide an estimated timeframe for our full response.
Do you offer remote consulting services?
Yes, we offer both remote and on-site consulting services. While we’re based in the Bay Area, we serve clients throughout the United States and internationally through our remote consulting options. Our virtual implementation approach has proven highly effective for many clients, particularly for organizations with multiple locations or those in regions where local expertise is limited.
How do I request a quote for your services?
You can request a quote by filling out the contact form on this page (select “Quote Request” from the subject dropdown), by emailing [email protected], or by scheduling a free consultation through our booking page. For the most accurate quote, please provide details about your organization size, industry, desired certification standard, current quality management maturity, and specific services needed.
Can I schedule a call to discuss my needs?
Absolutely! We offer free, no-obligation consultation calls to discuss your specific needs and how we can help. You can schedule a call directly through our booking page, or contact us through this form to request a call at a specific time.
Ready to Work with Our Expert Team?
Take the first step toward certification success with a free, no-obligation consultation. Discuss your specific needs with our experts and discover how we can help you achieve your quality management goals.
Expert Quality Management Consulting
Phone: (925) 557-8570
Email : [email protected]
Location: 499 Highland Dr, Danville CA 94526