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

ISO 13485:2003 Medical devices ... systems conform to all the requirements of ISO 9001. All requirements of ISO 13485:2003 are specific to ... ISO 13485 :1996 ...

ISO 13485 - Wikipedia

ISO 13485 Medical devices ... whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained.

In the news

Portal wins ISO certification for needle-free drug delivery device

-4 days ago

Medical device start-up Portal Instruments said today that it won ISO 13485:2012 certification from the National Standards Authority of Ireland. The Cambridge, Mass.-based company is developing a hand-held, needle-free drug delivery device. The device can ...

Portal wins ISO certification for needle-free drug delivery device

-4 days ago

Champion Manufacturing receives ISO 13485 Certification

-6 days ago

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

-2 weeks ago

ElectroMedical Technologies Takes Stand Against Opioid Use with Drug-Free Bioelectronic Medical Device

-2 days ago

Pre-certified medical air system solutions from Atlas Copco Compressor Technique

-1 week ago


ISO 13485 Quality Management System | Medical Devices ...

Demonstrate compliance to regulations with an ISO 13485 Quality Management System: ... What is an ISO 13485 Quality Management System? ISO ... Medical device training.

DEKRA Certification ISO 13485-Medical Device Quality ...

DEKRA ISO 13485 Certification for Medical Device Quality Management System. DEKRA Product Certification Medical Devices ... To view other available medical services ...

FDA cGMP, QSR and ISO Certifications for Medical Devices ...

... ISO 13485 and ISO 14971 and IEC 62304 standards by providing training and consulting. Our team of ISO ... QSR and ISO Certifications for Medical Devices.

Accredited Certification to ISO 13485 - Medical Devices

... and use of the ISO 13485 Medical Device initiative ... > The IAF Initiative for Accredited Certification to ... IAF Initiative for Accredited Certification to ...

ISO 13485:2012 - Quality Management Systems for Medical ...

... Quality Management Systems for Medical ... of medical devices. ISO 13485:2012 is ... of medical devices to be ISO 13485:2012 certified with ...

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 ...

ISO 13485 Consulting and Certification - Emergo

We specialize in helping medical device and IVD companies achieve ISO 13485 ... ISO 13485 Consulting and Implementation ... on our ISO 13485 consulting ...

ISO 9001:2008 36-Hour Certified Lead Auditor with Medical ...

ISO 9001:2008 36-Hour Certified Lead Auditor with Medical Device Focus (ISO 13485:2016 – Exemplar Global Certified) ... Lead Auditor with Medical Device Focus (ISO ...


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