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Medical Devices
Compliance Services
Ensure Regulatory Confidence. Enable Global Market Access.
At Cyberintelsys, we help medical device manufacturers, digital health innovators and healthcare technology providers achieve end-to-end regulatory compliance across global medical device frameworks. Our services integrate regulatory strategy, risk management, cybersecurity, software validation and lifecycle governance to ensure devices are safe, effective, secure and audit-ready.
We support the complete compliance lifecycle from design and classification to certification, post-market surveillance and continuous compliance aligning with EU MDR (2017/745), FDA 510(k), IEC 60601, IEC 62443 and IEC 81001-5-1 standards.
Medical device compliance ensures that devices and health software meet applicable regulatory, safety, performance and cybersecurity requirements before and after market release.
Our compliance services ensure that your medical devices meet EU MDR and FDA regulatory expectations, align with global safety and performance standards such as IEC 60601, integrate secure software and cybersecurity controls in line with IEC 81001-5-1, address OT and connected system security risks under IEC 62443 and maintain effective post-market surveillance and lifecycle compliance.
To help organizations design, validate, certify and maintain compliant medical devices while reducing regulatory risk, accelerating approvals and embedding cybersecurity and quality best practices throughout the device lifecycle.
Faster Regulatory Readiness
Accelerate FDA, EU and global submissions with detailed structured gap analysis and documentation support.
Integrated Cybersecurity & Software Compliance
Embed security-by-design and lifecycle cybersecurity controls aligned with regulatory guidance.
Documentation & Traceability
Maintain complete traceability across design, risk, testing and clinical evidence.
Reduced Regulatory & Safety Risk
Minimize audit findings, additional information requests and post-market incidents.
Certification & Market Access
Prepare thoroughly for regulatory review, notified body audits and global certifications.
Regulatory Strategy & Device Classification
FDA device classification and predicate analysis, EU MDR classification (Class I–III) and conformity route definition.
Design & Development Documentation
Align design controls, verification & validation records with FDA QSR, ISO 13485, IEC 62304 and MDR Annex II & III.
Risk Management & Clinical Evaluation
Conduct ISO 14971 risk management, usability engineering (IEC 62366), clinical evaluation and PMCF support.
Software & Cybersecurity Compliance
Integrate FDA cybersecurity guidance, MDR Annex I (17), IEC 81001-5-1 and secure SDLC practices.
Safety & Performance Compliance (IEC 60601)
Support essential performance definition, EMC, usability, collateral and particular standard alignment.
Testing & Validation Support
Bench testing, usability testing, EMC coordination, cybersecurity testing and verification planning.
Compliance as a Service
01
Continuous Security Monitoring
Ongoing vulnerability monitoring, threat detection and security posture reviews.
02
Patch & Vulnerability Management
Lifecycle management of device software, firmware updates and security remediation.
03
Post-Market Surveillance & Vigilance
Manage PMS systems, provide PSUR support, trend analysis and incident reporting.
04
Regulatory & Documentation
Keep technical files, risk registers and compliance evidence submission ready.
05
Supplier & Component Security
Assess cybersecurity risks across software components and dependencies for compliance.
06
Audit & Advisory Support
Support regulatory inspections, notified body audits and internal compliance reviews.
Our Engagement Approach
Implementation & Control Alignment
Embed security, safety and quality controls into design and operational processes.
Policy & Documentation Development
Develop MDR technical files, FDA design history files, ISMS/SDLC documentation.
Discovery & Gap Assessment
Assess regulatory readiness, QMS maturity, risk management and cybersecurity posture.
Continuous Improvement & Monitoring
Provide long-term advisory, monitoring and regulatory update support.
Submission & Certification Support
Support FDA submissions, MDR conformity assessments and certification engagements.
Testing & Validation Oversight
Guide verification, validation, usability, EMC and cybersecurity testing activities.
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Experienced Regulatory & Cybersecurity Experts
Hands-on experience across FDA, EU MDR and global medical device standards.
End-to-End Lifecycle Coverage
From concept and design to certification and post-market compliance.
Risk-Based, Practical Approach
Controls tailored to device criticality, patient safety and operational realities.
Unified Compliance Framework
One engagement covering MDR, FDA, IEC 60601, IEC 81001-5-1 and IEC 62443.
Sustained Compliance & Market Trust
Long-term support to maintain safety, security and regulatory confidence.
Brands That Trust Our Security Expertise
Protect Your Business from Emerging Cyber Threats
Cyberintelsys helps you stay one step ahead of today’s advanced cyber risks. Our expert-led penetration testing and security assessments are designed to identify vulnerabilities before attackers do helping you strengthen your security posture and meet compliance standards. Fill out the form, and we’ll get back to you with a tailored solution.
Frequently Asked Questions
Quick Answers to Your Cyber Security Concerns
EU MDR, FDA 510(k), IEC 60601, IEC 81001-5-1, IEC 62443, ISO 13485, ISO 14971.
Yes. We support SaMD, AI/ML-based devices and connected health platforms.
Yes. We assess and apply compensating controls for legacy systems.
Yes. Our CaaS model supports PMS, cybersecurity and regulatory maintenance.
No. Our approach integrates compliance efficiently into development workflows.