Design Control Procedure Bundle | ISO 13485 | FDA QSR Compliant

SKU: DESIGN-BNDL
$399.00
$399.00
Unavailable
per item
The ISO 13485 Design Control Procedure Bundle includes design control and related procedures that adhere to the design control requirements of ISO 13485:2016 and FDA QSR. 
  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • Includes All Related Forms
  • MS Word and Excel Format
  • Digital Content - Instant Download

ISO 13485 Design Control Procedure Bundle

​The Design Control Procedure Bundle includes four (4) commonly purchased design control standard operating procedures drafted in accordance with ISO 13485:2016 and FDA 21 CFR Part 820. 

ISO 13485 Design Control Procedure Bundle Contents

The ISO 13485 Design Control Procedure Bundle includes:
Design Control Procedure -The Design Control Procedure defines a systematic approach applied to medical device product design in compliance with ISO 13485:2016 and FDA Design Control requirements.
Design Review Procedure -The Design Review Procedure is centered on the systematic review of new product design, extensions to existing lines, and design modifications requiring design control. Includes Design Review Forms.
Design Transfer Procedure -The Design Transfer Procedure provides instruction on the transfer of medical devices from design and development to manufacturing. 
Design Verification and Validation Procedure -The Design Verification and Validation Procedure addresses the design verification and validation elements of the design and development cycle.

ISO 13485 Design Control Procedures Compliance

The Design Control Procedure Bundle is FDA 21 CFR Part 820 and ISO 13485:2016 compliant.
For more information about our ISO 13485 Design Control Procedure Bundle contact us at info@aplyon.com ​

Design Control Bundle Contents

design control procedure
Design Control
design verification and validation
Design V & V
design review procedure
Design Review
design transfer procedure
Design Transfer

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