Design Control Procedure Bundle | ISO 13485 | FDA QSR Compliant

SKU: DESIGN-BNDL
$499.00
$499.00
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

Customer's also viewed

Design Control Procedure | ISO 13485 | FDA QSR Compliant

$149.00

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
view

Design Review Procedure | ISO 13485 | FDA QSR Compliant

$149.00
The ISO 13485 Design Review Procedure establishes the systematic review of medical device development projects at logical points in the design process.  The ISO 13485 Design Review Procedure includes detailed review forms to document the entire design review process.​
  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • Includes Related Forms
  • MS Word Format
  • Digital Content - Instant Download
view

Medical Device Quality Management System | DESIGN PLUS

$3,199.00

The DESIGN PLUS Quality Management System (QMS) is configured for companies engaged in research and development of medical devices but perform no manufacturing (Specification Developers). The Design Plus QMS system is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance. Products installed in 43 countries and growing!​

  • Quality Management System Manual
  • 46 Procedures and Related Forms (MS Word and Excel)
  • ISO 13485:2016 and FDA QSR Compliant
  • MDR EU 2017/745 Compliant​​​​​
  • Digital Content - Instant Download 
view

Medical Device Quality Management System | MANUFACTURING PLUS

$4,499.00

The Medical Device Quality Management System | MANUFACTURING PLUS System is our "top line" QMS product configured for companies engaged in the design and manufacture of medical devices seeking ISO 13485:2016 certification and FDA QSR compliance. Products installed in 43 countries and growing!​

  • Quality Management System Manual
  • 72 Procedures and Related Forms (MS Word and Excel)
  • ISO 13485:2016 and FDA QSR Compliant
  • MDR EU 2017/745 Compliant​​​​​
  • Digital Content - Instant Download ​
view
Copyright © 2010-2020