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Two-level process validation approach for medical devices.

Yeong-Lin Chen¹

¹a Validation Department , SHL Group , Taoyuan , Taiwan.

Journal of Medical Engineering & Technology

|June 19, 2019

Summary

This summary is machine-generated.

This study proposes a two-level process validation approach for the diverse medical device industry, covering component production and device assembly. This adaptable strategy addresses unique manufacturing needs, unlike rigid pharmaceutical guidelines.

Keywords:

Medical device process validation case study equipment validation IQ/OQ/PQ process validation PQ two-level process validation

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Area of Science:

Biomedical Engineering
Medical Device Manufacturing
Quality Assurance

Background:

Medical device manufacturing involves diverse technologies, lacking specific validation guidance compared to pharmaceuticals.
Existing guidance necessitates adaptable process validation strategies for the medical device sector.

Purpose of the Study:

To propose a practical, two-level process validation approach for medical device manufacturing.
To address the unique challenges in validating processes within the diverse medical device industry.

Main Methods:

Developing a two-level validation framework: component production and device assembly.
Analyzing medical device manufacturing characteristics and relevant industry guidance.
Illustrating the approach with a case study.

Main Results:

A structured, two-level process validation model is presented.
The model integrates component production and device assembly validation.
A case study demonstrates the practical application of the proposed approach.

Conclusions:

The proposed two-level validation approach offers a flexible and effective strategy for the medical device industry.
This framework enhances process control and ensures product quality in medical device manufacturing.
Adaptable validation is crucial for meeting the diverse needs of medical device production.