Design Risk Management Procedure

$139.00
$139.00
Unavailable
per item

The ISO 14971 Design Risk Management Procedure focuses on design elements of the risk management process. The design risk management procedure is aligned with the requirements of ISO 14971:2019. 

  • EN ISO 14971:2019 Compliant
  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • ​MDR (EU) 2017/745 Compliant
  • Includes Related Forms
  • MS Word and Excel Format
  • Digital Content - Instant Download
SKU: SOP 7-030

Design Risk Management Procedure

The Design Risk Management Procedure defines the process for conducting design risk analysis for risks associated with medical products. This procedure is made part of the overall risk management process. 

Design Risk Management Procedure - Overview

The Design Risk Management Procedure provides detailed instruction on the following steps:
  • ​Preparation Steps
  • Risk Identification
  • Risk Estimation
  • ​Preliminary Risk Level 
  • Risk Control Measures
  • ​Re-Estimation of Risk Post Implementation of Controls
​​The Design Risk Management Procedure includes excel spreadsheets and related forms with instructions for each step of the process.

Design Risk Management Procedure - Compliance

​The Design Risk Management Procedure complies with requirements of EN ISO 14971:2019. The Design Risk Management Procedure is  also FDA QSR and ISO 13485:2016 compliant.
To learn more about our ISO 14971 Design Risk Management Procedure contact us at [email protected]

RELATED LINKS

​Risk Management Procedure Bundle
​Risk Management Procedure
Process Risk Management Procedure
​Design Control Procedure
Design Analysis Procedure​
ISO 14971 Design Risk Management Procedure
ISO 14971 Design Risk Management

Customer's also viewed

Risk Management Procedures Bundle | ISO 13485 | FDA QSR Compliant

$499.00

The Risk Management Procedure Bundle includes four (4) ISO 14971:2019 compliant standard operating procedures relating to the risk management process for medical devices. 

  • EN ISO 14971:2019 Compliant
  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • MDR EU 2017/745 Compliant
  • ​Includes Related Forms
  • MS Word and Excel Format
  • Digital Content - Instant Download
view

Medical Device Quality Management System | BASE PLUS SYSTEM

$1,799.00

The Medical Device Quality Management System | BASE PLUS is configured for companies engaged in the design and manufacture of medical devices who need only the minimum required content to obtain ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!​

  • Quality Management System Manual
  • 38 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 | DESIGN PLUS

$2,699.00

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 46 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

$3,599.00

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 46 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 © 2010-2024
  •