Our ISO 13485:2016 (+MDD) checklist covers all requirements of the standard, as well as the European Medical Device Directive (EU MDD 93/42/EEC) that apply to all medical devices. This checklist...

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Our ISO 13485:2016 (+ FDA Requirements) checklist uses 120 audit items to covers all requirements of the standard, as well as the United States FDA Quality Systems Regulations (21 CFR...

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Prior to marketing your medical device in Canada, you must comply with the QMS requirements of the Canadian Medical Devices Regulations (CMDR) and obtain the required level of approval from...

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Our OEC 62304 is the most comprehensive and easy-to-use checklist that covers all requirements for Medical Device Software Engineering (from documentation, record, design, and other processes). Our checklist tells you...

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[ISO 13485] Our ISO 13485:2016 checklist covers all requirements of the standard, as well as the regulations that apply to all medical devices. This checklist covers medical devices from Class I...

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