Medical devices

Medical devices

We can help you meet your regulatory and quality requirements for medical devices.

We can help you meet your regulatory and quality requirements for medical devices.
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Medical devices

We provide rigorous quality management reviews and product certifications for medical device manufacturers around the world, and we can do it for you too. 

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Medical device quality management certification


ISO 13485 Quality Management for Medical Devices

ISO 13485 is the internationally recognized standard designed to help manufacturers comply with regulatory systems and understand what they need to do to place compliant devices on markets throughout the world.

Find out how to be certified to ISO 13485 >

Medical device product certification

With thousands of mandatory and voluntary product certifications available (all of which vary from one global market to another), navigating and confirming the standards can be very complicated. We can identify technical requirements, product testing and certification schemes for most countries in the world including CE marking, Speed-to-Market Programs, FDA 510K Review, CMDR and CMDCAS, JPAL, Hong Kong CAB and Australia CAB.

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Medical device training courses