# Pricing IQ/OQ/PQ Process Validation Into a Medical Device Quote

> Source: https://netray.co/resources/validation-iq-oq-pq-cost-in-medical-device-quotes
> Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems.
> Section: Knowledge Base

## Short answer

How medical device contract manufacturers price process validation: IQ/OQ/PQ scope, sample sizes, protocol writing, re-validation triggers and billing.

## Category

ai-automation

## Content

**Intro:** IQ/OQ/PQ validation should be quoted as its own NRE line item, scoped per process and per part family, because it takes weeks of engineering and quality time and a failed or repeated run costs real material. Installation qualification confirms the equipment is installed per spec, operational qualification challenges the process window, and performance qualification proves it makes conforming product repeatably. For a contract manufacturer, the cost is driven by the number of processes needing validation, the sample sizes the risk level demands, measurement system work and who writes the protocols. Typical project cost runs from low thousands for a simple repeat process to tens of thousands for a complex or sterile-barrier process.

**Sections:**

#### What Actually Needs Validating

**Body:** ISO 13485 clause 7.5.6 requires validation of production processes whose output cannot be fully verified by later inspection. Think welding, sealing, molding of critical features, passivation, cleaning, laser marking legibility, and sterilization (clause 7.5.7). A turned titanium screw whose every dimension is measured does not need the same validation as a heat-sealed pouch where seal strength is tested destructively on samples. List each process on the part's routing and mark it verifiable or not. Only the not-fully-verifiable ones need IQ/OQ/PQ; the rest need verification and a documented rationale. This single list is the foundation of the validation line on your quote.

#### Where the Cost Comes From

**Body:** Most of the cost is people hours and consumed material, not equipment time. Protocol and report writing, engineering for the worst-case settings in OQ, three consecutive PQ lots at a defined quantity, inspection of every sample, and measurement system analysis on the gauges all add up.

**Bullets:**

- Protocol, risk assessment and report drafting and review cycles
- OQ challenge runs at low, nominal and high parameter settings
- Three PQ lots of representative size, with full inspection
- Gauge R&R and calibration evidence for the measurements used
- Material consumed, including scrap from deliberately challenged runs

#### Sample Sizes and the Statistics Behind Them

**Body:** Sample sizes should come from a risk-based rationale, not habit. For attribute data, a success-run approach (for example 59 consecutive passes demonstrates 95 percent reliability at 95 percent confidence, 29 passes gives 90 percent at 90 percent) is common and easy to explain to auditors. For variable data, capability index targets such as a Ppk threshold set by risk drive the count. Higher-risk features need higher confidence and more samples, which directly multiplies inspection hours and material. Put the assumed sample sizes in the quote so the customer sees why a critical sterile-barrier feature costs more to validate than a non-critical bracket dimension.

#### Re-Validation Triggers to State in the Quote

**Body:** Validation is not once and done. Write the triggers into your terms so a later change is a billable event with a defined scope, not a surprise argument.

**Bullets:**

- Customer drawing revision that touches a validated feature
- Change of raw material grade, supplier or form
- New or relocated equipment, new tooling cavity or major repair
- Software or firmware change on a validated machine or inspection system
- Negative trend or failure investigation that points to the process

#### Tracking Validation Cost So the Next Quote Is Better

**Body:** Most shops cannot say what their last five validations actually cost, because hours land on a generic project or overhead code. Open a dedicated job or project for each validation in your ERP with labor codes for protocol writing, run time, inspection and report review. After a few projects you have real numbers by process type to use in quotes. If the project is a one-off for a customer that will never return, or the validation is customer-owned and you only execute their protocol, say so and bill time and materials instead of building a complex fixed price. Fixed-price validation only works when the scope is well bounded.

**Cta:** Netray can mine your ERP's job history for what past validations actually consumed, so the validation line on your next device quote is based on your own hours, not a guess.

**Faq:**

#### How much does IQ/OQ/PQ validation cost for a contract manufacturer?

**Answer:** It varies widely with the process. A simple repeat process with an existing protocol template may take a few days of engineering and some material. A new sterile-barrier seal or molding validation can run into tens of thousands of dollars once protocol writing, three PQ lots, testing and report review are counted. Track your own hours by process type to quote with confidence.

#### Does every process on a medical device need IQ/OQ/PQ?

**Answer:** No. ISO 13485 requires validation where the output cannot be fully verified by subsequent monitoring or measurement. Processes whose results you inspect completely can use verification instead. Document the decision and the risk rationale for each process on the routing so an auditor can see it was a deliberate choice.

#### Who pays for re-validation after a drawing change?

**Answer:** Whoever your terms say. Best practice is to state in the quote that changes to validated features, materials or equipment trigger re-validation scope and cost, with milestone billing, so the conversation about price happens at the change request, not after the work is done.

## Related Slugs

- healthcare-medical-device-erp
- gross-margin-analysis-manufacturing
- syteline-job-costing-configuration-guide
- spc-integration-erp-quality

## Search terms

IQ OQ PQ cost medical device, process validation cost contract manufacturer, how to price validation in a quote, ISO 13485 7.5.6 process validation, medical device process validation sample size, OQ PQ revalidation triggers

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