ISO 13485 Process Validation Procedure Bundle

$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
SKU: PROCESS-BNDL

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 [email protected] 
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

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