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At Cyberintelsys Consulting Services, we help medical device and digital health technology providers achieve full compliance with EU MDR 2017/745 the comprehensive regulation governing safety, performance, cybersecurity and post-market obligations for medical technologies in Europe.
Our services cover the full EU MDR lifecycle from device classification and technical documentation to cybersecurity integration, post-market surveillance and CE marking readiness ensuring safe, compliant and market-ready products.
EU MDR establishes strict requirements for medical device safety, performance, risk management and cybersecurity. It governs all stages of a device’s lifecycle, from design and development to market entry and post-market monitoring.
To help organizations implement EU MDR requirements efficiently, integrating regulatory strategy, cybersecurity, risk management, documentation and post-market surveillance reducing regulatory risk and enabling faster market access.
Faster Compliance Readiness
Accelerate MDR alignment with structured gap assessments, risk analysis and technical documentation support.
Integrated Cybersecurity & Software Safety
Embed secure software lifecycle practices across design, development and manufacturing stages.
Documentation & Proof
Maintain audit-ready technical files, risk registers, clinical evaluation reports and cybersecurity evidence.
Reduced Regulatory Risk
Ensure compliance with MDR, ISO 14971, IEC 62304 and IEC 81001-5-1 standards to minimize audit issues.
Confidence in CE Marking
Be fully prepared for Notified Body audits with guidance from experienced regulatory professionals.
Initial Gap Assessment & Readiness Analysis
Evaluate device documentation, QMS processes and cybersecurity posture against MDR requirements.
Device Classification & Conformity Route
Determine class, applicable annex and conformity assessment pathway.
Technical Documentation & Clinical Evaluation
Compile design, risk, performance and clinical evidence aligned with Annex II & III.
Risk Management & Cybersecurity Integration
Apply ISO 14971, IEC 62304 and IEC 81001-5-1 principles across the lifecycle.
QMS Implementation & Optimization
Align ISO 13485 processes with MDR requirements for traceability, control and audits
Post-Market Surveillance & Vigilance Support
Establish PMS systems, incident reporting and periodic safety update reports (PSUR).
Compliance as a Service
01
Technical Documentation Maintenance
Ensure audit-ready technical files, clinical reports and risk registers are up to date.
02
Cybersecurity & Software Lifecycle Monitoring
Ongoing assessment, patch management and security validation for connected devices.
03
Risk Management Oversight
Continuous monitoring of hazards, usability and risk mitigation effectiveness.
04
Regulatory Advisory
Keep clients informed of MDR updates, guidance and evolving EU regulatory requirements.
05
Post-Market Surveillance Support
Monitor field performance, manage vigilance reporting and update PSURs as needed.
06
Audit & Notified Body Readiness
Assist with audits, inspections and CE marking submission readiness.
Our Engagement Approach
Documentation & Clinical Evaluation Development
Compile Annex II/III-compliant design, validation and clinical evidence.
Device Classification & Conformity Pathway
Determine class, intended use and regulatory route.
Gap Assessment & Planning
Identify readiness gaps in technical files, QMS and cybersecurity processes.
Certification Readiness & Lifecycle Maintenance
Support Notified Body audits, CE marking submissions and ongoing regulatory compliance.
QMS Optimization & PMS Establishment
Implement ISO 13485-aligned processes and post-market monitoring systems.
Risk & Cybersecurity Integration
Embed risk management and secure software practices throughout the device lifecycle.
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Certified Regulatory & Cybersecurity Experts
Professionals with hands-on experience in EU MDR, ISO 14971, IEC 62304 and IEC 81001-5-1.
Comprehensive End-to-End Support
From gap assessment to CE marking readiness and post-market surveillance.
Standards-Aligned Methodology
Implementation aligned with EU MDR Annexes, ISO standards and global best practices.
Tailored Documentation & Controls
Custom strategies, technical files and risk management processes adapted to your device type.
Continuous Compliance Maintenance
Ongoing advisory, cybersecurity monitoring and PMS support for sustainable MDR alignment.
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Frequently Asked Questions
Quick Answers to Your Cyber Security Concerns
EU MDR is the regulatory framework governing safety, performance and post-market obligations for medical devices in the EU.
Depending on device complexity, it typically takes 1–3 months to achieve full alignment and CE marking readiness.
Yes. We compile, review, and maintain Annex II/III documentation, clinical reports and risk registers.
Absolutely. We align Annex I (17) security requirements with IEC 81001-5-1 and secure software practices.
Yes. Our Compliance as a Service (CaaS) ensures ongoing PMS, vigilance, documentation maintenance and regulatory advisory.