Frameworks
Medical device quality that ensures safety with ISO 13485
Medical device failures risk patient safety, trigger recalls, and create regulatory consequences that threaten your business.
Tidal builds your Medical Device Quality Management System. Implement device-specific quality controls, maintain regulatory compliance, and demonstrate systematic quality management throughout the device lifecycle.
ISO 13485 in depth
ISO 13485 is fundamentally a quality management system tailored to medical device requirements. Organisations often treat it as documentation for regulatory compliance, missing the systematic quality management that ensures device safety and effectiveness.
Without systematic quality management, device failures, regulatory non-compliances, and post-market issues emerge reactively. This creates patient safety risks and regulatory consequences.
By implementing ISO 13485 as a management system, quality becomes embedded in device development, production, and post-market activities. This ensures patient safety, regulatory compliance, and sustainable medical device business.
How Tidal helps you get certified
Hit the ground running
Start with our pre-built controls, policies, and risk assessment templates.
Our platform guides you through establishing your ISMS scope, identifying assets, and implementing right-sized controls that match your business needs.
Why Tidal Control
We understand your challenges because we've been there. Our team of GRC experts and security professionals built Tidal to solve the real problems compliance teams face every day.
Made in Europe
Built and hosted in Europe. Your compliance data stays in the EU for full control and peace of mind.
Continuous automation
Automated evidence collection from cloud providers and development tools working 24/7 for you.
Real security
Build secure systems that protect your business and satisfy auditors, not just check compliance boxes.
Go beyond ISO 13485
Explore complementary frameworks that strengthen your medical device quality strategy.
ISO 9001
Broadening quality management beyond medical devices? ISO 9001 provides a foundation for general quality management that complements ISO 13485's device-specific requirements.
ISO 27001
Securing medical device data and connected devices? ISO 27001 protects patient data, device software, and quality records from cyber threats increasingly relevant for digital health technologies.
GDPR
Processing patient data in medical devices? GDPR ensures personal health information handled by your devices complies with European privacy requirements.
NEN 7510
Operating in healthcare? NEN 7510 provides the Dutch healthcare information security standard that complements ISO 13485 with sector-specific requirements for protecting medical information.
Integrate with your existing tools
Testimonials
What our customers say
With a single click, one Tidal test checks dozens of disks for encryption. Doing that manually would take a lot of time.
Frequently asked questions
ISO 13485 is the international standard for Quality Management Systems specific to medical devices. It's essential for manufacturers, distributors, and service providers of medical devices who need to demonstrate regulatory compliance and systematic quality management.
While based on ISO 9001, ISO 13485 focuses specifically on medical device requirements, emphasising risk management, design controls, traceability, and regulatory compliance. It's tailored to meet the unique quality and safety demands of medical devices.
Our platform maintains the quality documentation and evidence required for regulatory submissions to bodies like FDA, MDR, and other authorities. We help you organise design controls, risk management files, and quality records in an audit-ready format.
Our platform guides you through ISO 14971 risk management processes, helping you identify hazards, assess risks, implement controls, and monitor effectiveness throughout the device lifecycle. Risk management integrates with your quality management system.
Tidal provides templates and workflows for design controls including design planning, inputs, outputs, verification, validation, and design changes. We help you maintain the traceability and documentation that regulators expect.
Our platform helps you systematically collect and analyse post-market data, manage complaints and adverse events, track corrective actions, and maintain surveillance reports. This supports both regulatory requirements and continual improvement.