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. 

Medical device quality management certification

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.

BS ISO 15223-2:2010

Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Symbol development, selection and validation

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