ISO 13485 Medical Device QMS Certification
Based on the ISO 9001 process approach to quality management, ISO 13485 helps organizations that provide medical devices or services meet regulatory requirements and establish a management system.
By certifying to ISO 13485, your organization will be able to:
- Demonstrate compliance to regulatory requirements
- Establish an effective system for risk management
- Communicate effectively with customers, suppliers and other interested parties about operational control
Certifying your quality management system to ISO 13485 increases your organization's access to both U.S. and international markets. For example, ISO 13485 certification meets Good Manufacturing Practice compliance in the United States.
NSF-ISR certifies any organization that manufactures medical devices, including unfinished implantable medical device components. NSF-ISR does not currently certify companies that produce finished implantable medical devices.
Ready to Begin the Process?
Contact us with questions or to receive a quote.
What Does the Future Hold for Remote Audits?
NSF-ISR Marks Guide
NSF-ISR Certification Process
News and Events
NSF-ISR Provides Alternate and Remote Audits for Management Systems Certification Due to COVID-19
April 3, 2020
Due to the evolving COVID-19 pandemic and impact on our clients, NSF International Strategic Registrations (NSF-ISR) has developed options to ensure the continuity of certification, while doing our part to protect our number one priority, the health and safety of our team members, colleagues and customers.
Meet and Celebrate the NSF International Strategic Registrations Team With #TeamTuesday
December 10, 2019
Join NSF-ISR as we celebrate our stellar team members every Tuesday on the NSF International Strategic Registrations LinkedIn page.
Internal Audits: Achieve Your Best System by Being Your Worst Critic
December 5, 2019
A strong internal auditing program can help organizations keep their systems working effectively by becoming their own worst critic to drive needed continual improvement.
Interested in Joining the NSF-ISR Advisory Council?
December 2, 2019
NSF International Strategic Registrations (NSF-ISR) is seeking new members for our advisory council. The NSF-ISR Advisory Council serves a critical function by ensuring all NSF-ISR programs maintain impartiality, which is vital to the quality of NSF-ISR’s work around the globe.