What cybersecurity evidence is needed for review?

Evidence may include risk assessments, threat models, security architecture, requirements traceability, software security records, testing results, SBOMs, and vulnerability management documentation.

What cybersecurity documents support CE marking?

Supporting documents can include cybersecurity risk assessments, threat models, architecture records, security requirements, SBOMs, testing reports, vulnerability management records, and traceability evidence.

How long does a CE marking engagement take?

It depends on device complexity and what evidence already exists. We give a fixed timeline in the plan before work begins.

Can Medysec review an existing CE documentation package?

Yes. Medysec can assess existing cybersecurity documentation, identify evidence gaps, map requirements, and define remediation needed for stronger conformity-assessment readiness.

Can Medysec support Notified Body cybersecurity queries?

Yes. Medysec can support cybersecurity documentation reviews and responses to Notified Body queries, including evidence clarification, remediation records, traceability, and testing documentation.

CE Mark Compliance

CE Marking with Cybersecurity Compliance for Connected Medical Devices

We help medical device manufacturers assess cybersecurity risks, build supporting evidence, and address applicable EU MDR and IVDR security requirements.

Discuss CE Mark Cybersecurity See EU Compliance Scope

Medysec Deliverables

What CE Mark Cybersecurity Deliverables Does We Provide

We translate cybersecurity assessment and testing into structured evidence that supports the technical documentation and the conformity process.

GSPR Cybersecurity Compliance Checklist
Cybersecurity Risk Management File
Software Security Documentation
Cybersecurity Documentation
Cybersecurity Verification & Validation Documentation
Cybersecurity Risk Assessment
Threat Modeling Report
Security Architecture Documentation
Cybersecurity Requirements & Controls Traceability Matrix
SBOM & Software Supply Chain Documentation
Vulnerability Assessment Report
Penetration Testing Report
Penetration Testing Retesting Report
Cybersecurity Incident & Vulnerability Management Documentation

Our Compliance Process

Our CE Mark Compliance Process Workflow

We identify the applicable requirements, complete the security work, and connect the evidence to the wider conformity process.

01
Cybersecurity Scope & Regulatory Assessment
Define the device, software, connectivity, intended use, target market, and applicable MDR/IVDR requirements.
02
Architecture & Attack Surface Assessment
Review architecture, data flows, interfaces, dependencies, cloud services, communications, and exposed attack surfaces.
03
Cybersecurity Risk & Threat Assessment
Identify assets, threats, vulnerabilities, attack paths, impacts, controls, and residual risks.

Standards & Framework

Standards and Frameworks We Follow

Our work is informed by the EU requirements and guidance relevant to your device and cybersecurity evidence.

Regulation (EU) 2017/745
Regulation (EU) 2017/746
MDR Annex I
MDR Annex II & III
IVDR Annex I
IVDR Annex II & III
MDCG Guidance Documents
MDCG 2019-11
MDCG 2019-16 Rev.1
MDCG 2020-1
MDCG 2020-16
MDCG 2025-10

Step-by-Step Workflow

How to Begin Securing Your MedTech Cybersecurity with Medysec

We analyze your device architecture, build complete cybersecurity evidence, and hand your team an audit-ready submission package.

01
Discovery & Artifact Plan
Our senior Medysec expert reads device architecture, intended use, regulatory pathway, and existing cybersecurity evidence then delivers a written artifact plan and fixed-fee quote inside 5 business days.
02
Authoring & Testing
Medysec runs hands-on threat modeling, SBOM authoring, security risk assessment, and penetration testing on the named device, using the agreed artifact plan as the work contract.
03
Internal Reviewer Simulation
Two named Medysec experts review the package against FDA 2026 guidance check-by-check before handoff. Findings flagged, retested, and closed.
04
Submission Hand-off
You get a one-hour walk-through with your regulatory lead, a Letter of Attestation, and a fixed-fee retest commitment if FDA raises cybersecurity deficiencies.

In Their Words

What Our Clients Say

We work alongside device manufacturers to secure their connected medical devices and clear regulatory review. Here is what those teams have to say about us.

Qualysec Technologies Pvt Ltd's efforts resulted in improved security, risk mitigation, enhanced security controls, and compliance achievement. The team was responsive, flexible, and open to addressing the client's evolving needs. They maintained regular communication via email and virtual meetings.
Billy Sadhu Sharma Kumar
Head-V&V Engineering

CE Mark Case Studies

Cybersecurity Evidence for CE Mark Readiness

Explore Case Studies

Diagnostic desktop application cybersecurity case study illustration

An European MedTech Startup Secures Its Diagnostic Desktop App With Medysec Ahead of FDA 510(k) Submission

A security assessment of a diagnostic desktop application used with the TearView platform, focused on protecting patient diagnostic data, strengthening application controls, and supporting the clientâ€™s FDA 510(k) documentation.

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