Automate the Complex.
Focus on What Matters.

CURA is a modular SaaS platform that automates complaint handling, regulatory reporting, and post-market surveillance for medical device companies.

It delivers real-time insights, ensures 100% audit compliance, and significantly reduces costs and manual errors - empowering teams to focus on innovation and quality.

The Modules

Automate your Life-Cycle

CURA is built on a modular architecture, allowing medical device companies to tailor their compliance and quality workflows. Each module is designed to automate a specific part of the product life-cycle - delivering precision, speed, and full regulatory alignment.

Complaint Handling

Automated Processing: Reduces manual workload and eliminates human error.
Faster Resolution: Speeds up complaint triage and follow-up actions.
Centralized Oversight: Provides a unified view of all complaints for better tracking and accountability.
Audit-Ready: Ensures every complaint is documented and traceable for regulatory inspections.

Adverse Event Reporting

Regulatory Compliance: Automatically formats and submits reports to authorities like FAERS and EUDAMED.
Standardization: Uses IMDRF/NCIT coding to ensure consistent and compliant reporting.
Real-Time Alerts: Flags critical events for immediate attention and action.
Global Readiness: Supports multi-region reporting requirements with ease.

PMS Trending & Reporting

Trend Detection: Identifies emerging issues through automated analysis of complaint and performance data.
Data-Driven Decisions: Supports continuous improvement in product design and manufacturing.
Custom Reports: Generates PMS reports tailored to regulatory and internal needs.
Performance Benchmarking: Tracks KPIs over time to measure product and process improvements.

Vigilance

Proactive Risk Management: Detects and escalates potential safety issues before they escalate.
Integrated Surveillance: Combines complaint data, adverse events, and trend analysis into one vigilance workflow.
Regulatory Alignment: Ensures compliance with EU MDR and FDA vigilance requirements.
Zero Gaps: Eliminates missed signals and ensures full lifecycle monitoring.

The Benefits

Excels in Productivity Gain

Welcome to Life-Cycle Management 2.0!
CURA transforms how medical device companies manage product life cycles - driving quality improvement, leveraging complaint and PMS data, and enhancing product design and performance. With 100% audit compliance, zero human error, and consistent, error-free processes, CURA sets a new standard in regulatory excellence.

>75%

Reduction of Costs

→ CURA dramatically lowers operational expenses, freeing up resources for innovation and growth.

>3500%

productivity increase

→ Teams can accomplish more in less time, transforming efficiency across the entire compliance workflow.

>95%

reduced processing time

→ Tasks that once took days are now completed in minutes, accelerating decision-making and responsiveness.

>90%

less compliance incidents

→ Automated processes minimize risk and ensure consistent adherence to regulatory standards.

100%

audit findings eliminated

→ With full traceability and error-free documentation, CURA delivers complete audit readiness - every time.

The Company

REMEDICAL is an independent, global life sciences consulting firm that offers a comprehensive suite of services to support improvements in Medical Device Engineering and Life Cycle process improvement. We are passionate engineers with more than ten decades experience in Medical Device/Life Science activities in the USA, Switzerland, Sweden, and Germany. REMEDICAL offers customers the ability to remediate, improve and quickly resolve unexpected events in dynamic competitive environments.

We're good with numbers

100+

Years of Experience

100K+

Medical Device Optimized

Millions

Patient Lifes Improved

15+

Countries Covered

Thousands

Complaint Data Points Generated

5+

Partners

The Compliance

Full Certification

CURA is fully compliant with ISO 13485 and ISO 27001, ensuring the highest standards in medical device quality management and information security.

Cybersecurity

CURA is hosted in Switzerland, uses fully encrypted databases, two-factor authentication, and adheres to the highest standards in cybersecurity to ensure data integrity and protection.

Task Assignment

CURA features a built-in messaging system and task assignment functionality, ensuring tamper-proof documentation and seamless alignment with standard operational workflows.

Ready to boost productivity?

Unlock faster workflows, zero errors, and full compliance.

CURA does the heavy lifting so your team can focus on what matters most.

Automate the Complex. Focus on What Matters.