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ISO 13485 - Wikipedia

ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard ...

ISO 13485:2003 - Medical devices -- Quality management ...

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related ...

ISO 13485:2016 - Medical devices -- Quality management ...

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related ...

In the news

Premiere Resource, the ISO Certified Division of Smart Source LLC, Demonstrates Documented Savings for Leading Medical Device Manufacturer

-1 week ago

MISSION VIEJO, Calif., April 11, 2017 /PRNewswire/ -- Premiere Resource, the ISO Certified division of Smart Source LLC, is an end-to-end service provider for the entire print, production and fulfillment process for the regulated industry. For this case ...

Premiere Resource, the ISO Certified Division of Smart Source LLC, Demonstrates Documented Savings for Leading Medical Device Manufacturer

-1 week ago

NEO Tech Adds ISO 13485 Medical Certification at its Chatsworth, CA Location

-1 week ago

Industry response to new EU laws on medical devices

-1 week ago

Skanska : Dexcom renovates warehouse into medical device manufacturing space

-4 hours ago

Medical device reporting: Reading between the lines

-1 day ago


ISO 13485 2016 Medical Device Quality Standard in Plain ...

Use ISO 13485 2016 to show that your organization is consistently capable of providing medical device products that meet customer expectations and comply with ...

ISO 13485 Consulting for Medical Device Manufacturers - Emergo

We specialize in helping medical device and IVD companies achieve ISO 13485 certification. Let us help you implement ISO or modify your existing QMS.

ISO 13485 Quality Management System | Medical Devices ...

ISO 13485:2016 is here. The world’s most popular standard for medical devices quality management has been revised for the first time since 2003.

Medical devices — Quality management systems ...

ISO (the International ... Medical devices — Quality management systems — Requirements for regulatory purposes 1 Scope 1.1 General ... medical device(s) ...

ISO Medical Device Standards - MasterControl Inc

Learn more about ISO Medical Device Standards and how MasterControl Audit software can streamline the audit process.

Understanding ISO 13485 - Quality Magazine

ISO 13485: 2003 represents the requirements that medical device manufacturers must incorporate into their management systems. The current document supersedes its 1996 ...

What is the relationship between FDA's Quality System ...

• Many other countries rely on ISO standards in regulating medical devices. It is easier and less confusing for industry to develop a quality system if the


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