의료기기 제조업자를 대상으로 하는 FDA QSR 컨설팅 (21 CFR Part 820)

Common FDA QSR and 21 CFR 820 compliance questions

Are Class II and Class I devices exempt from QMS requirements?

No. It is important to note that Class II devices and most Class I devices are not exempt from QSR (current Good Manufacturing Practice) requirements.

My company already has ISO 13485 - is that sufficient?

The FDA does not recognize ISO 13485 as compliant with FDA QSR (21 CFR Part 820). However, if you already have ISO certification, we can assist you in integrating FDA quality system requirements into your existing quality management system.

How long does it take to implement FDA QSR - 21 CFR Part 820

The amount of time needed to comply with 21 CFR Part 820 varies depending on the number of facilities, complexity of your manufacturing process, level of management support, and whether someone in the company is fully dedicated to quality management. Our experience shows most medical device and IVD manufacturers can implement a QSR-compliant quality management system in three to seven months.

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