CERTIFICATIONS
ClariMed is ISO 13485:2016 Certified
At ClariMed, we hold ourselves to the highest standards of quality in human-centered medical device development. We are proud to share that we earned our ISO 13485:2016 certification through BSI in July 2025. This milestone validates our comprehensive service portfolio across quality management systems, regulatory affairs, and medical device design and development.
CERTIFICATIONS
ClariMed is ISO 13485:2016 Certified
At ClariMed, we hold ourselves to the highest standards of quality in human-centered medical device development. We are proud to share that we earned our ISO 13485:2016 certification through BSI in July 2025. This milestone validates our comprehensive service portfolio across quality management systems, regulatory affairs, and medical device design and development.
CERTIFICATIONS
ClariMed is ISO 13485:2016 Certified
At ClariMed, we hold ourselves to the highest standards of quality in human-centered medical device development. We are proud to share that we earned our ISO 13485:2016 certification through BSI in July 2025. This milestone validates our comprehensive service portfolio across quality management systems, regulatory affairs, and medical device design and development.
What This Means for Our Partners
By operating with the exact same quality standards as leading medical device companies, we empower our clients to innovate with confidence. Partnering with our ISO-certified team provides several key advantages:
Global Credibility: Our certification provides your projects with enhanced credibility for regulatory submissions to the FDA, EU MDR, and other global regulatory bodies.
Consistent Excellence: Our clients receive consistent, high-quality deliverables from our teams across all of our global office locations.
Rigorous Processes: Every deliverable we produce is backed by rigorous quality processes designed to optimize development and ensure patient safety.
What This Means for Our Partners
By operating with the exact same quality standards as leading medical device companies, we empower our clients to innovate with confidence. Partnering with our ISO-certified team provides several key advantages:
Global Credibility: Our certification provides your projects with enhanced credibility for regulatory submissions to the FDA, EU MDR, and other global regulatory bodies.
Consistent Excellence: Our clients receive consistent, high-quality deliverables from our teams across all of our global office locations.
Rigorous Processes: Every deliverable we produce is backed by rigorous quality processes designed to optimize development and ensure patient safety.
Certification Details
The following table outlines the specifics of our registration:
Certification Details
The following table outlines the specifics of our registration:
Certification Details
The following table outlines the specifics of our registration:
Certifying Body
BSI
Certificate Number
MD 825736
Standard
ISO 13485:2016
Effective Date
2025-07-02
Expiry Date
2028-07-01
Scope of Certification
Consultancy services in the area of quality management system, regulatory affairs, design and development for medical device and in-vitro diagnostic medical device manufacturers.
View Our Official Certificate
For your vendor records and compliance requirements, you can access and download our official certificate below.
WEBINARS
Bringing Knowledge to Your Desktop
Can't make it to our in-person events? No problem! Our webinars offer a convenient way to access valuable insights and expertise from the comfort of your own office. Join our upcoming webinars to deepen your understanding of key topics in medical device development, human factors engineering, and regulatory compliance.
WEBINARS
Bringing Knowledge to Your Desktop
Can't make it to our in-person events? No problem! Our webinars offer a convenient way to access valuable insights and expertise from the comfort of your own office. Join our upcoming webinars to deepen your understanding of key topics in medical device development, human factors engineering, and regulatory compliance.
WEBINARS
Bringing Knowledge to Your Desktop
Can't make it to our in-person events? No problem! Our webinars offer a convenient way to access valuable insights and expertise from the comfort of your own office. Join our upcoming webinars to deepen your understanding of key topics in medical device development, human factors engineering, and regulatory compliance.
Our Latest Webinars
Let's work together!
Contact us to discuss how we can advance your medical device development efforts together.
Let's work together!
Contact us to discuss how we can advance your medical device development efforts together.
Let's work together!
Contact us to discuss how we can advance your medical device development efforts together.
ClariMed, Inc. 2026. All rights reserved.
ClariMed, Inc. 2026. All rights reserved.
ClariMed, Inc. 2026. All rights reserved.