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...

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...

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...

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...

[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...