Product Stability Shelf-Life Procedure | ISO 13485 | FDA QSR Compliant

$149.00
$149.00
Unavailable
per item
The Shelf Life Procedure defines the required testing needed to support medical device shelf life claims. The Shelf Life Procedure provides instruction on product considerations, accelerated aging studies, and post accelerated aging product testing and reports. 
  • ASTM F 1980-16 Compliant
  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • MS Word Format
  • Digital Content - Instant Download
SKU: SOP 7-026

Medical Device Shelf Life Procedure

​The Shelf Life Procedure defines the required testing needed to support medical device shelf life claims. The Shelf Life Procedure provides instruction on product considerations, accelerated aging studies, and post accelerated aging product testing and reports.

Shelf Life Procedure - Overview

​The Shelf Life Procedure provides instruction on conducting accelerated aging and concurrent real time aging studies. The Shelf Life Procedure includes guidance on the preparation of product stability protocols and considerations, and the required content of a stability protocol.

Shelf Life Procedure - Compliance

​The Shelf Life Procedure is FDA QSR and ISO 13485:2016 Compliant.
To learn more about our Medical Device Shelf Life Procedure contact us at [email protected]

RELATED LINKS

​​Design Control Procedure
​Accelerated Aging Study Protocol
Medical Device Quality Management System DESIGN PLUS
​Medical Device Quality Management System MANUFACTURING
​Medical Device Quality Management System MANUFACTURING PLUS
Shelf Life Procedure
Shelf Life Procedure

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