QUALITY & MANUFACTURING

Quality at every step.

SkyCade Med supports medical device production through quality systems and controlled environments.

QUALITY & MANUFACTURING

Precision backed
by process.

SkyCade Med’s manufacturing capabilities are supported by established medical device quality systems and controlled production environments.

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ISO 13485Medical device quality management

ISO 14971Medical device risk management

21 CFR Part 820FDA quality system requirements

ISO 14644-1Class 100 cleanroom

ISO 8573Compressed air standards

Sterile & non-sterileManufacturing with Class I and Class II device expertise

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