Our manufacturing process hasn't changed in years. Does it still need to be validated?

Existing processes must still be documented as validated. Additionally, any change — new material supplier, new equipment, facility relocation — triggers revalidation or change control activities. We audit your process history and identify gaps.

IQ · OQ · PQ · IEC 62304

Validation That Stands Up in Any Audit — IQ, OQ, PQ and Beyond

Whether you're validating a manufacturing process, a sterilization cycle, a cleaning procedure, or an embedded software system, MEGACERT writes validation protocols and reports that satisfy ISO 13485 QMS requirements and MDR Technical File expectations.

Request a Validation Planning Session →

Validation Under ISO 13485 and EU MDR — What Manufacturers Must Know

ISO 13485:2016 Clause 7.5.6 requires that manufacturers validate any process where the resulting output cannot be fully verified by subsequent inspection or testing. Under EU MDR, validation evidence must also be included in the Technical Documentation — meaning your validation packages are not just QMS documents but regulatory submission artifacts.

The three categories of validation most frequently required:

Manufacturing Process Validation — Ensuring that a manufacturing process consistently produces a product meeting its predetermined specifications.
Cleaning & Sterilization Validation — Particularly critical for reusable instruments and devices with patient contact. ISO 17664, EN ISO 11135, EN 556 compliance.
Software Validation (IEC 62304) — For medical device software (MDSW) and software as a medical device (SaMD), a lifecycle-based validation approach per IEC 62304 and FDA 21 CFR Part 11 / EU MDR Article 22.

Our validation specialists have supported hundreds of IQ/OQ/PQ studies across Europe, the US, and Turkey — from Class I instruments to complex active implantable systems.

Validation Deliverables

Validation Master Plan (VMP)

Site-level or product-level document defining validation scope, responsibilities, methodologies, acceptance criteria, and schedule. Foundation of your validation program.

Installation Qualification (IQ)

Documented verification that equipment and systems are installed according to manufacturer specifications and regulatory requirements. Includes equipment description, calibration records, utility requirements.

Operational Qualification (OQ)

Documented testing demonstrating that equipment and systems operate within predetermined limits across the specified operating range — under worst-case conditions.

Performance Qualification (PQ)

Documented testing demonstrating that the process, using qualified equipment, consistently produces a product meeting specifications under actual or simulated production conditions.

Software Validation Package (per IEC 62304)

Software development plan, risk classification (Class A/B/C), software requirements specification, architecture, unit/integration/system testing, anomaly resolution, and validation summary report.

Cleaning Validation

Soil definition, cleaning agent selection justification, sampling methodology, acceptance criteria setting, and validation report per ISO 17664 / ISO 15883.

Frequently Asked Questions

Yes, if the software influences device safety or performance. IEC 62304 classifies software as Class A (no injury), Class B (non-serious injury), or Class C (serious injury/death) — and the required lifecycle activities scale with this classification. MEGACERT performs software safety classification and plans the proportionate validation approach.

Ready to build validation packages that pass Notified Body and FDA scrutiny? Contact MEGACERT for a free validation planning session.