Vigilance Procedure

SKU: SOP 8-009
$149.00
$149.00
Unavailable
per item
The Vigilance Procedure provides instruction on classifying incidents to determine reportability and instruction on overall reporting process.  The Vigilance Procedure Includes a Vigilance Decision Tree. ​
  • ​ISO 13485:2016 Compliant
  • MDR EU 2017/745 Compliant
  • MS Word Format
  • ​Instant Download Digital Content

Vigilance Procedure

The Vigilance Procedure provides instruction on requirements for reporting on serious incidents and field safety corrective actions. The Vigilance Procedure Includes vigilance decision tree and related forms. ​

Vigilance Procedure - Overview

The Vigilance Procedure, and applicable decision trees, will determine if the incident meets the three basic reporting criteria in order for an incident to be classified as reportable and provides instruction on how to report  a reportable incident.

Vigilance Procedure - Compliance

The Vigilance Procedure is MEDDEV 2.12-1, Medical Device Regulation, Health Canada, Medical Device Regulation MDR 2017/745 and ISO 13485:2016 compliant.
For more information about our Vigilance Procedure contact us at info@aplyon.com 

RELATED LINKS

​Complaint Handling Procedure Bundle
Medical Device Reports (MDR)
Complaint Handling Procedure
​​Medical Device Quality Management System MANUFACTURING
​Medical Device Quality Management System MANUFACTURING PLUS
Vigilance Procedure
Vigilance Procedure

Customer's also viewed

Complaint Handling Procedure | ISO 13485 | FDA QSR Compliant

$149.00
The ISO 13485 Complaint Handling Procedure governs the process for receiving, reporting, investigating, documenting and closing medical device complaints. 
  • Comprehensive Complaint Data Capture Form
  • Includes Decision Trees (FDA MDR, Canadian, European)
  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • ​MDR EU 2017/745 Compliant
  • MS Word Format
  • Digital Content - Instant Download
view

Complaint Handling Procedures Bundle | ISO 13485 | FDA QSR Compliant

$499.00
The ISO 13485 Complaint Handling Procedure Bundle groups together a series of  ISO 13485 quality system  procedures related to the management of medical device complaints.  
  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • MDR EU 2017/745 Compliant
  • Includes All Related Forms
  • MS Word Format
  • Digital Content - Instant Download
view

Medical Device Quality Management System | MANUFACTURING

$2,899.00

The Medical Device Quality Management System | MANUFACTURING product is designed for companies engaged in both product development and the manufacture of medical devices. The system is rich in content and provides detailed instruction governing research and development, manufacturing and post commercialization activities. The 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
  • 60 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