Medical Device Process Validation Overview

Jan 17, 2023

Process validation is an important part of the production lifecycle, as it ensures that processes are operating correctly and efficiently. It is a way to verify that a process meets its intended purpose and produces consistent results. It is also required by the regulators to ensure your devices are properly designed and manufactured to comply with the industry’s regulations and standards. 

In this article, we provide an overview of the medical device manufacturing validation process:

The Medical Device Process Validation Process

1. Establish Design Requirements

The first step when setting up process validation is to establish your design requirements.

This will inform how the product should be developed and give you a benchmark for how you should be validating later in the process.

Make sure to develop acceptance criteria and design controls for keeping track of your design requirements for easy reference.

The Difference Between Design Validation and Process Validation

Design validation is an important part of the product development process, as it ensures that the device meets user needs and intended uses. It involves creating evidence to demonstrate that the design meets these requirements.

Process validation, on the other hand, focuses on the production of the device. This includes ensuring that all processes are in place to produce a quality product consistently.

Most companies follow FDA requirements for design control 820.30 and ISO 13485 standard clause 7.3 when performing validation during the final stage(s) of product and process development sequence. However, planning begins with the initial design control process implemented by R&D which helps identify device quality characteristics and process variables.

This allows for a more thorough understanding of how each component affects overall performance and reliability of the device before it goes into production. By combining design validation and process validation, companies can ensure that their products meet both user needs and regulatory standards while also being produced efficiently and cost-effectively.


2. Create a Process Flow Chart

A process flow chart will help your team visualize production, assembly, and inspection processes.

The chart should show where critical components are used while also helping identify potential defects or errors in the manufacturing process.

Technicians will use visual process controls to ensure that each assembly step is performed properly.


3. Specify Operational and Qualification Procedures

With established design requirements and flow charts, operating procedures and documentation can be planned.

Plan clarity is important so that everyone understands the steps required and their purpose during each stage.

The purpose of the Operational and Qualification stage is to ensure that protocols for process validation for a specific manufacturing process are clearly defined and reported.

Written protocols ensure that our process validation is consistent across the technicians team and over the entire life of a manufacturing process.

4. Validate the Process Parameters

Process parameters are those which define how your product specifications can be met without fail during each stage of production. Adding or removing features as well as testing materials used in manufacturing, or process equipment functionality for example.

All parameters should be validated using data-driven techniques before starting mass production of devices on commercial scale.


5. Develop Inspection Procedures

Creating inspection procedures will enable manufacturers to check quality control at each stage of production, so that defective or non-conforming parts don’t make it through into final assemblies which could pose risks for consumers using medical devices later on . Clarify who should conduct inspections before moving forward with actual inspections in real-time operations on the factory floor.

6. Monitor & Test Products Using Statistical Quality Control (SQC) Methodology

Finally, consider conducting sampling tests utilizing Statistical Quality Control (SQC) methodology in order to ensure products meet detailed regulatory expectations such as safety standards pertaining to human body interaction , accuracy requirements etcetera in terms of performance outcomes prior to market launch . In addition , monitoring products throughout their entire life cycles is also a key part of ensuring best practices are maintained throughout their many months in use by end users at domestic and clinical environments.

How Quasar Can Help

Quasar provides medical device manufacturers with the expertise and capabilities to navigate the validation process. With a custom-tailored approach and exclusive validation activities, Quasar helps manufacturers shepherd their innovative products through validation for compliance and top product quality. 

Quasar Medical has over 30 years of experience in the medical device industry and understands the complexities of validating a product or process.

We provide guidance on how to ensure that your product meets all regulatory requirements while also helping you develop an efficient validation plan that is tailored to your specific needs. Additionally, we assist with developing protocols for testing processes and equipment as well as providing support during the implementation phase. Our services are designed to help you save time and money while ensuring that your product meets all necessary standards for safety and efficacy.

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