ISO 13485
ISO 13485 is a Quality Management System for medical device/component manufacturers. This includes any organization that designs, produces, installs, or services medical devices and components.
Due to the vital nature of such products, conformity is paramount. As a globally-recognized standard, ISO 13485:2016 makes product conformity possible amidst expanding international supply chains.
ISO 13485 certification helps medical device manufacturers meet industry requirements and regulations. As a global standard of medical device quality, ISO 13485 opens your business to more markets, ensuring compliance with internationally recognized best practices and safety protocols.
ISO 13485 Certification
In the medical device industry, quality and safety are crucial. The International Organization for Standardization (ISO) developed ISO 13485 to standardize the quality and safety requirements for medical devices worldwide. With ISO-compliant quality management, you can reduce risk in the supply chain and increase customer satisfaction.
By meeting ISO 13485 requirements, you empower your business to move forward and engage new markets. The medical device manufacturing requirements of ISO 13485 set your business apart. They prove your commitment to quality and safety, building trust with consumers as you continually deliver safe, effective products and components.
ISO 13485 certification also streamlines your day-to-day manufacturing processes. With an ISO 13485 management system, you get more value from your operations, increasing productivity and cost-efficiency across your organization.
You must complete several steps to achieve and maintain certification. Certificates are issued by a third-party registrar following a certification audit, and everyone in your organization will need to be involved in the process. To learn more about the basics of certification, download our free guide or contact us to speak with a consultant.
Consulting Support for ISO 13485
Core makes certification as simple and effective as possible. Whether onsite or online, our consultants handle the complicated parts of ISO 13485 so that you can focus on your business. We’ll help you understand how the standard applies to your specific organization. Implemented properly, ISO 13485 gives you a continual return on your investment.
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What are the Benefits of ISO 13485 Certification?
When you pursue ISO 13485 certification with us, you get more than a piece of paper. You get a quality management system that can transform your business. As a medical device manufacturer, you can leverage this certification to demonstrate quality control measures and compliance with industry regulations.
ISO 13485 certification offers many benefits for small manufacturers and provides opportunities to engage a larger market.
Effective Risk Management
QMS Practices for Safe and Effective Medical Devices
Foundation for Compliance with FDA, MDD or CE
Improved Processes
New Business Opportunities
Effective Risk Management
QMS Practices for Safe and Effective Medical Devices
Foundation for Compliance with FDA, MDD or CE
Improved processes
New Business Opportunities
Effective Risk Management
ISO 13485 gives you the tools for effective risk management, creating consistency across your organization to ensure safe and reliable products.
QMS Practices for Safe and Effective Medical Devices
ISO 13485’s Quality Management System (QMS) practices establish protocols for quality control, ensuring safe and effective products. With compliant oversight, monitoring, and accountability, you can consistently meet critical requirements for medical device production.
Foundation for Compliance With FDA, MDD or CE
ISO 13485 certification is a common first step for manufacturers seeking compliance with the Medical Device Directive (MDD) and the CE marking process in the European Union.
Many countries now base their regulatory requirements on ISO 9001 and 13485. For example, the U.S. revised Quality System Regulation (FDA 21 CFR 820) incorporates both standards.
ISO 13485 references the ISO 9001:2008 standard, not the latest 2015 version. However, ISO 13485 goes beyond ISO 9001 with many controls specific to medical devices.
Improved Processes
ISO 13485 requirements help you streamline their regular processes. With the monitoring and evaluation required by ISO 13485, you can establish efficient systems and optimize productivity across your organization.
New Business Opportunities
Because ISO 13485 requirements are recognized world-wide, certification exposes you to a broader market. When you demonstrate compliance with a proven, globally-recognized standard, you can engage with new customers.
Related Standards
We provide consulting support for various other standards, as well as support for companies seeking multiple certifications through an Integrated Management System.
ISO 9001
Quality Management Systems
ISO 14001
Environmental Management Systems
ISO 45001
OH&S Management Systems
ISO 9001
ISO 45001
ISO 14001
For more information about ISO certification for the ISO 13485 standard, please call our consulting office at 866-354-0300 or contact us online.
Set Up Your Business for ISO 13845 Success Today
When you partner with Core Business Solutions, you receive cloud-based tools and consulting help to make ISO 13485 certification simple, fast, and effective. We’re committed to helping small businesses achieve success and satisfy customers.
We offer consulting, software, training, and educational resources to get your entire team on board with ISO 13485. Our approach makes ISO 13485 understandable and effective, so you can meet industry criteria and optimize your processes.
For more information about the ISO 13485 standard, please call our consulting office at 866-354-0300 or contact us online.