Design Control Procedure | ISO 13485 | FDA QSR Compliant

$149.00
$149.00
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per item

The Design Control project management procedure defines a systematic approach to medical device development in compliance with ISO 13485:2016 and FDA 21 CFR Part 820 design control requirements and the establishment of compliant Design History Files (DHF's). 


  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • ​MDR EU 2017/745 Compliant​​
  • MS Word Format
  • Digital Content - Instant Download
SKU: SOP 7-001

ISO 13485 Design Control Procedure

The Design Control project management procedure defines a systematic approach applied to medical device product development in compliance with ISO 13485:2016 and FDA Design Control requirements. 

Design Control Procedure Overview

​The Design Control Procedure provides detailed instruction to help design teams follow logical FDA and ISO 13485 compliant phases. The Design Control Procedure identifies design tasks by phase, overall design considerations, action items and required testing (by phase). The Design Control Procedure outlines specific departmental tasks and responsibilities throughout product development. 

The Design Control Procedure provides instruction on the structure and content of Design History Files (DHF's). The Design Control Procedure provides the critical foundation to help design team manage all medical device design and development projects.

Design Control Procedure Compliance

The Design Control Procedure is 21 CFR Part 820, MDR 2017/745 and ISO 13485:2016 compliant.
To learn more about our Design Control Procedure contact us at [email protected]
ISO 13485 Design Control Procedure
ISO 13485 Design Control Procedure

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