Successful pilot builds show that a medical device can be manufactured. It does not establish that the manufacturing process will consistently deliver the same results across production shifts, material lots and operators.
For medical device OEMs preparing to launch, scale or transfer production, process validation provides evidence that defined manufacturing processes can consistently meet established requirements. Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) help organize that evidence.
Understanding these stages also helps OEMs ask better questions when evaluating a contract manufacturing partner.
What are IQ, OQ and PQ in medical device manufacturing?
IQ confirms that equipment and supporting systems are installed according to approved requirements. OQ establishes operating limits that produce acceptable results. PQ demonstrates that the process consistently meets defined requirements under anticipated production conditions. Together, they support a documented approach to medical device process validation.
Process validation is required when production output cannot be, or is not, verified through subsequent monitoring or measurement and, as a result, deficiencies would become apparent only after the product is used or the service is delivered.
ISO 13485:2016 addresses this requirement in Clause 7.5.6. The FDA’s Quality Management System Regulation (QMSR) incorporates ISO 13485:2016 by reference into 21 CFR Part 820.
Processes commonly evaluated for validation include bonding, welding, molding, cleaning, sterilization and sterile barrier sealing. The appropriate scope depends on the operation, its risks and the effectiveness of available verification methods.
For example, a finished device might pass a functional test while a bonded joint contains a weakness that the test cannot detect. If evaluating that joint requires destructive testing, inspecting every finished unit is not a practical way to establish conformity.
For OEMs, the key question is: Which product requirements can we verify through inspection and testing, and which depend on a validated process?
Each stage answers a different question about manufacturing readiness.
| Stage | Primary question | Typical evidence |
|---|---|---|
| Installation Qualification (IQ) | Is the equipment installed correctly? | Equipment identification, installation checks, utilities, calibration and configuration records |
| Operational Qualification (OQ) | What operating limits produce acceptable results? | Challenge testing, justified parameter ranges and predefined acceptance criteria |
| Performance Qualification (PQ) | Does the process perform consistently under production conditions? | Results from representative production runs, materials, personnel and procedures |
The GHTF process validation guidance hosted by IMDRF provides practical background on this framework. Although it predates the current ISO edition, it remains a useful explanation of the qualification stages.
Installation Qualification documents that equipment and supporting systems meet approved installation requirements. It establishes the foundation for meaningful operational testing.
Depending on the process, IQ may address:
Cleanroom requirements apply where the product and process require them; they are not universal requirements for every medical device assembly operation.
What OEMs should ask: Can the manufacturer connect the installed equipment and configuration to the approved requirements and supporting records?
Operational Qualification evaluates whether the process produces acceptable results across justified operating limits. Testing only the preferred setpoint can leave important sources of variation unexplored.
An OQ protocol should identify parameters that influence quality and explain how relevant limits and worst-case combinations will be challenged. Depending on the operation, those parameters might include temperature, pressure, time, speed or curing conditions.
Consider a sealing process. Testing at the nominal temperature alone does not establish an acceptable operating range. Temperature, pressure and dwell time may interact, so the study needs to justify its test conditions and assess the relevant quality attributes.
Alarms, interlocks and fault responses should also be evaluated where they affect process control.
What OEMs should ask: What evidence supports the approved process limits, and how will production prevent or detect operation outside them?
Performance Qualification evaluates the process under anticipated production conditions using approved procedures, suitable materials and trained personnel.
The study should represent relevant sources of variation, such as:
Engineering support may be appropriate, but it should not hide problems that routine production personnel would encounter. Results need to be assessed against predefined acceptance criteria, with deviations investigated and resolved.
Three successful runs are not a universal PQ requirement. The number of runs and samples should have a documented rationale based on process risk, variability and applicable requirements.
What OEMs should ask: Does the study represent how the device will actually be manufactured after launch or transfer?
For complete medical device assembly, validation planning needs to fit the entire manufacturing flow. A finished device may involve validated operations, in-process inspections and final functional testing. Each control should address a defined requirement.
Before approving a manufacturing transfer, review these five areas with your contract manufacturer:
A validation master plan can help organize a complex program, but the document’s title is less important than the evidence it contains.
Agree on documentation access, approval responsibilities and change notification expectations early. A certificate of conformance or a summary report alone may not provide enough detail to determine whether the validation covers your device and manufacturing conditions.
These discussions also support the broader transition from pilot builds to repeatable commercial production.
A validated process needs ongoing oversight. Changes or adverse quality trends can affect whether the original evidence still supports current production.
Reasons to assess the need for revalidation include:
Evaluate the impact through change control and document the decision. Some changes may need focused testing; others may require broader qualification or validation.
An OEM transferring production should not assume that validation at the original facility automatically applies to the receiving site.
Even a detailed validation package can leave unanswered questions. Watch for:
Addressing these gaps during manufacturing planning can help prevent avoidable delays when production is ready to move forward.
Validation supports confidence in process consistency. It does not replace design validation, required product acceptance activities or ongoing quality oversight.
Choosing a manufacturing partner involves understanding how that partner will control the processes behind your finished device.
Sanbor Medical brings more than 30 years of production experience to medical device contract manufacturing, including complete device assembly. Early collaboration can help OEM teams clarify assembly requirements, testing needs, documentation and validation responsibilities before production begins.
Whether you are preparing a new build, increasing volume or evaluating a supplier transfer, bring your device specifications, expected volumes, current manufacturing stage and known process challenges to the discussion.
Discuss your medical device manufacturing project with Sanbor Medical.
IQ means Installation Qualification, OQ means Operational Qualification and PQ means Performance Qualification. These stages address equipment installation, acceptable operating limits and consistent process performance under anticipated production conditions.
No. The decision depends on whether the process output can be, and is, adequately verified through subsequent monitoring or measurement. Validation is required under the applicable ISO 13485 criteria when unverified deficiencies would become apparent only after use or service delivery.
No. Three successful runs are not a universal requirement. The number of runs and samples needs a documented rationale based on risk, process variability and applicable requirements.
Not when the applicable validation criteria are met. A final inspection or functional test may verify some device characteristics while leaving other process-related attributes unverified.
A contract manufacturer can perform agreed qualification and validation activities within its capabilities and quality system. The OEM and manufacturer should define responsibilities, protocol approvals, documentation access and change controls before work begins.
A production transfer requires an assessment of its effect on the validated process. Changes in equipment, utilities, personnel, environment or materials may require additional qualification or validation. The scope should follow a documented evaluation.
