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Replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC)
The regulation went into effect May 26, 2021 (Date of Application). This date was delayed due to Continue Reading
ISO 13485 is a voluntary quality system standard
Generic in nature
Management is held accountable for the quality management system
Appropriate for medical device manufacturers, contract manufacturers, component manufacturers, service Continue Reading
This is a quality system regulation, not a voluntary standard
The QSR is generic in nature due to the fact that there are more than 12k devices in the marketplace Continue Reading
This is a voluntary quality system standard, each organization has the flexibility to implement their quality system in a manner that is most appropriate to them
Not industry-specific
Management is Continue Reading
ADVANCED QUALITY SYSTEM SOLUTIONS
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