Medical Devices Compliance Automation
Validator streamlines validation, centralizes documentation, and keeps your medical device quality system audit-ready—enabling safe innovation and faster regulatory approvals.
Compliance That Moves With Your Products
Medical device manufacturers must meet demanding regulations from FDA, EU (MDR/IVDR), and global authorities, while maintaining full product traceability and design history. Each new product, process, or market requires careful validation and documentation through all lifecycle stages—that’s a tall order with paper-based systems or inflexible generic software.
Validator gives medical device companies a faster, smarter path to compliance. Designed by practitioners with deep device experience, Validator automates every step of the validation, qualification, and QMS documentation workflow. No more chasing records, struggling with version control, or dreading audit questions—just streamlined, audit-ready operations from design to post-market.
Tailored for Device Regulatory Demands
Validator’s automation is purpose-built for device workflow:
- End-to-End Equipment & Process Qualification: Generate, route, and store IQ, OQ, PQ, and process validation records—complete, consistent, and easy to find for every product and revision.
- Integrated Design History & QMS: Maintain up-to-date design history files, validation records, and change logs in a single, GAMP 5-, MDR-, and 21 CFR Part 11-compliant system.
- Cleaning, Maintenance, and Requalification: Track cleaning validation, requalification schedules, and protocol updates for instruments and manufacturing environments—so nothing is missed during inspections or product changes.
- ERP/LIMS/QMS Integration:
Validator syncs with your production, lab, and quality management systems, eliminating silos and redundant data entry.
Technical Strength and Regulatory Confidence
- Compliant with FDA 21 CFR Part 11, EU MDR/IVDR Annexes, ISO 13485, and GAMP 5 best practices
- Secure, timestamped e-signature workflows and full audit trail for every document
- Built-in impact assessment and change control to maintain validated state through device updates, transfers, and new site launches
Business Impact for Medical Device Companies
- Accelerate Device Launches: Reduce validation and documentation lead times, supporting faster submissions and market entry.
- Easy, Reliable Audit Prep: Maintain instant access to all qualification, process, and design history records, making audits and regulatory submissions less stressful.
- Fewer Errors, More Innovation: Free your team from paperwork bottlenecks and give them more time to focus on R&D, design improvements, and product quality.
- Proven Success: Device makers trust Validator to keep them compliant—no matter how complex their portfolio or how fast they scale.
Who Should Use Validator?
From startup device innovators to global OEMs, any company that requires robust, scalable validation and QMS documentation will benefit from Validator’s automation and expertise.
Tailored Automation For Every Validation
Validator is designed to tackle your biggest compliance pain points either one process at a time or across your entire validation lifecycle.
Explore each core solution to see how Validator can streamline your work and strengthen your audit confidence.
Computer System Validation (CSV)
Validator automates every phase of system validation, from protocol creation to risk management and compliance documentation. Records and traceability are built in and reliable, keeping your systems audit-ready at all times.
Process Validation (PV)
Experience more control and fewer surprises with automatic protocols, batch records, and trend data integration. All three stages of process validation—design, qualification, ongoing review—move faster and smarter with Validator.
Equipment Qualification (EQ)
Keep every asset documented and up to date. From installation through annual verification, Validator manages every protocol, document, and calibration so you’re always ready for inspection.
Cleaning Validation
Cleaning schedules, procedures, and proof are managed for you. Auditors get instant access to every record, while your team has more time for high-value work.
Compliance That’s Proactive, Integrated, And Ready For What’s Next
Not all platforms are created equal. Validator is shaped by experience—built and implemented by people who have worked inside life sciences teams, led audits, and solved real regulatory problems.
Constant Compliance
Real-time dashboards create a living audit trail, so your team works from current data and your compliance stays inspection-ready.
Integrated With Your Systems
Every connection is fully configurable to your LIMS, ERP, MES, HR, finance, and risk systems with no custom code, so you can access and personalize without calling IT.
Fast ROI with Proven Efficiency
Achieve over 40% efficiency gains and 100% implementation success. Fast ROI with Validator fully configured and running smoothly within 3 months.
Always Up-to-date
As regulatory standards evolve, so does Validator, to ensure your validation system follows CSA and globally aligned practices for international compliance.
Frequently Asked Questions
Can Validator manage validation and documentation for multiple device types and global markets?
Yes. Validator is fully configurable for a wide range of devices and manufacturing processes, and supports regulatory requirements for FDA, EU MDR/IVDR, ISO 13485, and other global standards.
How does Validator help maintain design history files (DHFs) and change control for devices?
Validator centralizes DHF documentation, automatically tracks changes, and provides a complete audit trail—making it easy to demonstrate compliance and manage updates throughout the device lifecycle.
Does Validator automate both equipment qualification and process validation in device manufacturing?
Absolutely. Validator covers IQ, OQ, PQ, cleaning validation, and process validation from initial setup to requalification—ensuring all records, approvals, and schedules are managed in one platform.
How does Validator support device companies preparing for FDA or notified body audits?
Validator maintains real-time, audit-ready records, instant document retrieval, and full traceability for every device, process, and protocol—so you’re always prepared for inspections, with confidence.
Testimonials
Here are a few of our client and their testimonials
