What is ISO 13485?

 

The ISO 13485 standard is for medical device/component manufacturers. Due to the vital nature of such products, conformity is paramount. The global acceptance of ISO 13485:2016 helps safeguard product conformity amidst expanding supply chains.

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.

Interested? Get a Free Quote.

What are the Benefits of ISO 13485 Certification?

When you pursue ISO 13845 certification with us, you get more than a piece of paper. You get a quality management system that can transform your business. ISO 13485 certification offers many benefits for small manufacturers:

Effective Risk Management

QMS Practices for Safe and Effective Medical Devices

Foundation for Compliance with FDA, MDD or CE

Improved Processes

New Business Opportunities

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With CORE’s platform, training and consultants we were able to succeed in a short time and gain a level of understanding and structure we otherwise would never have been able to accomplish.

Anne Mills on BirdEye

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The certification process was easy and painless. Suzanne Weber-Smatko did an excellent job of preparing us for the audits and we were certified with no findings.

-Elizabeth Meighan on BirdEye

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C&C International was indeed very pleased with the Core training we’ve recently received. Suzanne Weber-Smartko and Norman Verbeck provided very good support and direction. We are very much satisfied with CORE.

Bill James on Google

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The Core Solutions team was excellent to work with and made the ISO preparation tolerable. I highly recommend the services of the Core Solutions.

-Paul Amalfitano on BirdEye

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Thanks to the CORE team and especially Bruce Newman for a great experience achieving our company’s first ISO certification.

-Flip Crummer on Facebook

Effective Risk Management

QMS Practices for Safe and Effective Medical Devices

Foundation for Compliance with FDA, MDD or CE

Improved processes

New Business Opportunities

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.

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 of these standards.

Additionally, 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.

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.

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