Medical Device Process Validation is critical before launching any medical device into the market. Manufacturers must ensure their manufacturing processes are capable, consistent, and compliant. Regulatory bodies like the US FDA and ISO 13485:2016 require manufacturers to verify and validate that processes consistently produce quality medical devices.
When product testing alone is insufficient, destroys the product, or doesn’t capture all potential variations, process validation becomes critical. As a trusted partner, Operon Strategist helps medical device companies design and implement robust validation strategies (IQ, OQ, PQ) that meet regulatory requirements while optimizing efficiency.
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How the US FDA Defines Process Validation
The FDA’s Quality System Regulation defines Medical Device Process Validation as:
“Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.” (21 CFR 820.75). FDA further mandates validation when results cannot be fully verified through inspection or testing. Similarly, ISO 13485:2016 Clause 7.5.6 requires validation for critical processes.
Operon Strategist specializes in creating documentation, risk-based analysis, and validation protocols aligned with these global standards.
Verification vs. Validation
- Verification: Confirms that a product meets design specifications (through inspection and testing).
- Validation: Confirms that the process consistently produces compliant devices, especially when direct verification is impractical or insufficient.
Design Validation vs. Process Validation
- Design validation ensures the device meets user needs and intended use.
- Process validation ensures the manufacturing process itself produces consistent and compliant outcomes.
Operon Strategist integrates design controls and process qualifications into clients’ Quality Management Systems (QMS) for end-to-end regulatory compliance.
Which Processes Require Validation?
According to FDA, ISO 13485, and IMDRF guidance, validation is required for processes such as:
- Sterilization and sterile packaging
- Cleanroom conditions
- Welding, soldering, and heat treatment
- Plastic injection molding
- Automated assembly and software-driven production
If destructive testing or limited sampling cannot guarantee device quality, process validation becomes essential.
Basic Steps in Process Validation
A structured validation approach includes:
- Establishing equipment and process capability
- Demonstrating repeatable performance through multiple runs
- Monitoring validated processes during routine production
- Periodic requalification and revalidation
Operon Strategist ensures clients follow systematic validation frameworks compliant with current FDA and ISO standards.
Forming Your Validation Team
A cross-functional team should include:
- Quality Assurance (QA)
- Engineering
- Risk Management
- Manufacturing and Production
Our experts at Operon Strategist can train internal teams or act as validation partners to streamline documentation and compliance.
The Process Validation Plan (PVP) & Master Validation Plan (VMP)
A Process Validation Plan (PVP) lays the foundation. It identifies:
- Scope and elements to validate
- Responsibilities across departments
- Documentation strategy
- Schedules and milestones
A Validation Master Plan (VMP) integrates all facility-level activities, including utilities, measuring tools, and interdependent processes. Operon Strategist helps clients prepare audit-ready VMPs with regulatory focus.
Process Validation Protocols
Well-written protocols ensure nothing is overlooked. They document:
- Process to be validated
- Equipment and operators involved
- Parameters and acceptance criteria
- Statistical methods for data analysis
- Criteria for revalidation
Operon Strategist can design IQ, OQ, and PQ protocols tailored to the complexity of equipment and processes.
IQ, OQ, PQ Explained
Installation Qualification (IQ)
- Confirms proper installation of equipment, software, utilities, and instruments against engineering specifications.
- Aligns with FDA 21 CFR 820.70(g) and ISO 13485.
Operational Qualification (OQ)
- Verifies equipment performance through all anticipated operating ranges.
- Challenges “worst-case conditions” to establish critical process limits.
Performance Qualification (PQ)
- Demonstrates that under normal production conditions, the process consistently produces acceptable devices.
- Confirms process stability, control, and long-term reproducibility.
At Operon Strategist, our team designs end-to-end IQ, OQ, PQ studies with comprehensive risk-based evidence.
When to Revalidate a Process
Revalidation is necessary when:
- Process, design, or software changes occur
- New facilities, equipment, or suppliers are introduced
- Trends show quality decline or rising complaints
Even without changes, periodic revalidation (every 2–3 years for critical processes like sterilization) may be advised.
Software Validation in Device Manufacturing
Under ISO/TR 80002-2:2017 and 21 CFR 820, software used in production or quality monitoring must be validated and revalidated. This applies to systems used in:
- Device design automation
- Manufacturing tracking
- Labeling and packaging
- Complaint handling systems
Operon Strategist offers support in software validation documentation, a key FDA inspection focus.
Get Started with Expert Medical Device Process Validation Today
Why Partner with Operon Strategist?
- Over a decade of expertise in medical device regulatory compliance
- Specialized services in Process Validation (IQ, OQ, PQ), QMS implementation, and ISO 13485 certification
- Tailored solutions to ensure cost-efficient, audit-ready validation
- Proven support for Indian and international device manufacturers entering regulated markets
FAQs
What is process validation in medical devices?
Process validation is the documented evidence that a manufacturing process consistently produces a medical device that meets predetermined specifications. It is required when product quality cannot be assured solely through inspection or testing.
Why is process validation necessary in medical device manufacturing?
It is necessary when:
Product testing is destructive.
Sampling cannot fully verify quality.
The process includes variables that may impact safety and effectiveness.
Regulatory bodies like the US FDA (21 CFR 820.75) and ISO 13485:2016 mandate process validation for such processes.
What is the difference between IQ, OQ, and PQ?
Installation Qualification (IQ): Confirms equipment and systems are installed correctly per specifications.
Operational Qualification (OQ): Verifies equipment operates within defined parameters and under worst-case conditions.
Performance Qualification (PQ): Demonstrates consistent, reproducible results under actual production conditions.
