ISO 13485 Process Validation Procedure Bundle

SKU: PROCESS-BNDL
$399.00
$399.00
Unavailable
per item

The ISO 13485 Process Validation Procedure Bundle includes 4 procedures related to the validation of medical device processes. The process validation procedures are ISO 13485:2016 and FDA QSR compliant.



  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • MS Word Format
  • Includes Related Form(s)
  • Digital Content - Instant Download

ISO 13485 Process Validation Procedure Bundle

​The Process Validation Procedure Bundle includes four (4) ISO 13485:2016 compliant procedures related to medical device process validation. 

Process Validation Procedure Bundle - Overview

  1. Process Validation Procedure - The Process Validation Procedure provides instruction for determining when process validation is required, validation pre-requisites, and overall strategy.  The procedure also includes information on worst case product selection, validation lots, test methods and acceptance criteria.
  2. ​Validation Protocols and Reports Procedure - The Validation Protocol and Report Procedure instructs on the development of Installation Qualification (IQ) Protocols, Operational Qualification (OQ) Protocols, Performance Qualification (PQ) Protocols and Product Performance Qualification (PPQ) Protocols.
  3. ​​Installation Qualification Procedure - The Installation Qualification Procedure applies to the installation of new equipment, moving or relocating equipment, or after equipment modifications. ​The Installation Qualification (IQ) Procedure provides instruction on the requirements of conducting Installation Qualifications (IQ's).​
  4. ​Statistical Techniques Procedure - The Statistical Techniques Procedure provides guidance on statistical analysis methods used to support medical device sampling plans, failure analysis and validation data analysis.

Process Validation Procedure Bundle - Compliance

The Process Validation Procedure Bundle content is ISO 13485:2016 and FDA QSR Compliant.
To learn more about our ISO 13485 Process Validation Procedure Bundle contact us at info@aplyon.com 
Process Validation Procedure Bundle Content
process validation procedure
Process Validation Procedure
installation qualification procedure
Installation Qualification Procedure
validation protocols and reports
Validation Protocols and Reports Procedure
statistical techniques procedure
Statistical Techniques Procedure

RELATED LINKS

Design Control Procedure Bundle
​Risk Management Procedure Bundle
Clinical Evaluation Procedure Bundle
Complaint Handling Procedure Bundle
Medical Device Labeling Procedure Bundle
​Medical Device Software Procedure Bundle
​Document Control Procedure Bundle
​Cleanroom Procedure Bundle

Customer's Also Viewed

Medical Device Process Validation Procedure

$149.00

The Medical Device Process Validation Procedure provides guidance on medical device process validations. The ISO 13485Process Validation Procedure applies to all medical device manufacturing processes requiring validation prior to the commercial release of product.

  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • MS Word Format
  • Digital Content - Instant Download
view

Statistical Techniques Procedure | ISO 13485 | FDA QSR Compliant

$149.00
The ISO 13485 Statistical Techniques Procedure provides guidance on statistical analysis methods used to support medical device sampling plans, failure analysis and validation data analysis. ​
  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • 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