ISO 13485 Medical Devices
Quality management system for medical device manufacturers
ISO 13485 Certification
ISO 13485 is an ISO standard which published in 2003 for a comprehensive quality management system for the design and manufacture of medical devices.
We provide a full range of services including ISO 13485 Consultant.
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What is ISO 13485
ISO 13485 is an ISO standard which published in 2003 for a comprehensive quality management system for the design and manufacture of medical devices. We provide a full range of services including ISO 13485 Consultant.
While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained.
ISO 13485 Focus On
Regulatory Requirements
The promotion and awareness of regulatory requirements as a management responsibility.
Work Environment Controls
Controls in the work environment to ensure product safety.
Risk Management
Focus on risk management activities and design control activities during product development.
Implantable Devices
Specific requirements for inspection and traceability for implantable devices.
Sterile Medical Devices
Specific requirements for documentation and validation of processes for sterile medical devices.
Corrective Actions
Specific requirements for verification of the effectiveness of corrective and preventive actions.
In addition, compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements.
Our Consulting Services
ISO 9001
Quality Management Systems
ISO 13485
Medical Devices QMS
ISO 14001
Environmental Management
ISO 22000
Food Safety Management
OHSAS 18001 / ISO 45001
Occupational Health & Safety
RSPO/MSPO
Sustainable Palm Oil
Standards Transition
Upgrade & Migration
Management Systems
Integrated Systems
Maintenance Program
Ongoing Support
ISO 13485 vs ISO 9001
While ISO 13485 is generally harmonized with ISO 9001, there are key differences that make it specifically suitable for medical device manufacturers.
Continual Improvement
Requires the organization to demonstrate continual improvement of the quality management system.
Effective Implementation
Requires only that the certified organization demonstrate the quality system is effectively implemented and maintained.
Industry Specific
Designed specifically for medical device industry with focus on regulatory compliance and product safety.
European Compliance
Seen as the first step in achieving compliance with European regulatory requirements.
Why Choose YHY for ISO 13485
Medical Device Expertise
Specialized knowledge in medical device manufacturing and regulatory requirements.
Regulatory Compliance
Deep understanding of international and European regulatory frameworks for medical devices.
Risk Management Focus
Expert guidance on implementing risk management throughout the product lifecycle.
100% Success Rate
Proven track record of successful ISO 13485 certifications across various medical device manufacturers.
Documentation Support
Comprehensive support in developing compliant documentation and validation processes.
Training Programs
Specialized training for your team on ISO 13485 requirements and implementation.
Ready to Get ISO 13485 Certified?
Contact us today for a free consultation and discover how ISO 13485 certification can benefit your medical device organization.