Process validation is one of the most important quality requirements in medical device manufacturing. It ensures that a production process consistently produces components that meet predetermined specifications. For medical devices and critical components such as extruded tubing, it is often impossible or impractical to fully verify quality through end-stage inspection alone. This is why regulators expect manufacturers to perform a structured validation process known as IQ, OQ, and PQ.

The United States Food and Drug Administration defines process validation as “the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”

This article explains each stage of IQ, OQ, and PQ, how they fit into medical device validation, and how extrusion manufacturers support OEMs through the process.

What Is Process Validation in Medical Devices

Process validation is required when the quality of a product cannot be fully verified through inspection and testing. Examples include extrusion, sterile barrier sealing, molding, and bonding. In these cases, destructive testing or impractical inspection methods make validation essential to ensure safety, performance, and regulatory compliance.

The primary regulatory foundations include:

• 21 CFR 820.75 within the FDA Quality System Regulation
• ISO 13485 requirements for process control and validation
• ISO 14971 risk management considerations

Together, these frameworks establish expectations for how OEMs validate manufacturing processes and how suppliers support that validation.

Starting in February 2026, ISO 13485 will be integrated into the new Quality Management System Regulation (QMSR) and will require process validation for the production of medical device products, with the FDA mandating process validation to ensure specifications are consistently met.

Understanding IQ, OQ, and PQ in Medical Device Process Validation

IQ, OQ, and PQ form a structured sequence:

• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification

This sequence is the backbone of process qualification across regulated industries and serves as a predictable roadmap for establishing process reliability.

Installation Qualification (IQ): Verifying Correct Installation

Installation Qualification answers the question “Is everything installed correctly?”

IQ verifies and documents that equipment, utilities, tooling, auxiliary systems, and measurement instruments are installed according to manufacturer specifications and facility requirements.

Typical IQ activities include:

• Verifying equipment installation and configuration
• Confirming utilities such as electrical supply, cooling, and compressed air
• Checking connections to ancillary devices
• Documenting calibration status and reference standards
• Organizing manuals, certificates, and supporting documentation
  

For extrusion processes, this often includes validating extruders, crossheads, downstream cooling systems, measurement tools, and material handling systems used to produce medical tubing.

OEMs rely on accurate IQ documentation because it establishes the foundation for the next two phases. Operational testing cannot occur until proper installation is confirmed.

Operational Qualification (OQ): Establishing Operating Limits and Controls

Operational Qualification answers two core questions:
“Is the equipment operating correctly?” and  “What are the operating limits of this process?”

OQ verifies that equipment functions within defined operational ranges and that critical parameters are stable, repeatable, and controllable. In extrusion, this often includes melt temperature, line speed, puller force, and cooling parameters.

Operational Qualification testing typically includes:

• Running the process at worst-case, nominal, and upper-limit settings
• Identifying potential failure modes
• Establishing acceptable control limits
• Verifying operational alarms or controls
• Defining action levels

This is the stage where engineers determine how shifts in temperature, pressure, or speed affect final tubing dimensions, mechanical strength, and surface quality.

Performance Qualification (PQ): Demonstrating Real-World Consistency

Performance Qualification answers two key questions:
“Does this process produce the correct result?”
“Is the process consistent under real production conditions?”

PQ verifies that the process reliably produces components that meet specifications over multiple production lots. PQ must be conducted under routine conditions, using trained personnel, approved materials, and final equipment settings.

Typical PQ activities include:

• Producing multiple lots at nominal settings
• Measuring dimensional accuracy across all lots
• Conducting tensile and mechanical performance testing
• Verifying surface integrity and concentricity
• Documenting lot-to-lot and within-lot consistency

For extrusion, PQ often includes tensile testing and dimensional characterization of tubing.

This stage demonstrates that the validated process is stable and capable of supporting commercial manufacturing.

Why IQ, OQ, and PQ Must Follow This Order

IQ confirms proper installation.
OQ confirms correct operation.
PQ confirms consistent performance.

If the order is reversed or skipped, validation loses its meaning. Regulators expect IQ, OQ, and PQ to occur sequentially because each phase provides evidence required to support the next.

For example, OQ limits cannot be established unless the installation has been verified, and PQ cannot begin until those limits are validated.

How ISO 13485 Shapes Process Validation Requirements

ISO 13485 requires manufacturers to validate any process where the output cannot be fully verified by inspection. Although MET does not claim ISO 13485 certification, MET supports OEMs that must comply with ISO 13485 by supplying:

• Detailed process parameters
• Material and additive traceability
• Measurement data for extrusion output
• Lot-specific records that support PQ testing
• Documentation needed for customer validations
  

This support reduces workload for OEM quality teams and ensures extrusion processes meet regulatory expectations.

When Medical Device Manufacturers Must Perform Process Validation

Processes requiring validation often include:

• Extrusion of polymer tubing
• Heat shrink and reflow bonding
• Molding
• Sterile barrier sealing
• Welding and soldering
• Coating and dipping
• Aseptic filling

If the performance of the output cannot be fully confirmed without destructive testing, the process must be validated. This applies whether the manufacturer is an OEM, contract manufacturer, or component supplier.

The European MDR and the FDA Quality System Regulation both require validation for processes where outcome cannot be fully inspected.

Ignoring validation can result in major non-conformities, audit findings, or product failures. It can also significantly delay market readiness, as shown in industry case studies from compliance experts.

Modern Approaches to Software and Equipment Validation

Historically, software used in manufacturing and quality systems also required IQ, OQ, and PQ. Today, the FDA supports a more efficient Computer Software Assurance approach.
https://www.fda.gov/media/160805/download

Although CSA is not the focus of extrusion processes, it impacts quality systems that support them.

How MET Supports IQ, OQ, and PQ for Extrusion Processes

As a specialized extrusion manufacturer, MET supports OEM validation efforts by:

• Providing material certifications and traceability reports
• Supplying extrusion parameter data for OQ testing
• Conducting tensile, dimensional, and mechanical testing for PQ
• Maintaining consistent lot-to-lot processes that align with customer validation protocols
• Documenting tooling, equipment, and measurement controls that inform IQ requirements
  

This collaboration helps OEMs complete process validation faster, reduces the risk of regulatory findings, and ensures stable long-term supply of validated extruded components.

MET offers advanced extrusion capabilities, including multi-lumen tubing, profile extrusions, and custom catheter shafts.Teams developing new components or scaling production can contact MET to support documentation, testing, and data packages that streamline their validation process.