Where does cybersecurity appear in IVDR?

Cybersecurity considerations connect with IVDR requirements for software lifecycle, risk management, information supplied to users, and protection against risks affecting safety and performance.

How does IEC 62304 apply to IVD software?

It defines the software lifecycle process, and the assigned safety class determines how deep the documentation has to go.

Can Medysec map existing security work to IVDR?

Yes. Medysec can review existing security evidence and map relevant assessments, controls, testing, risks, and documentation against applicable IVDR cybersecurity expectations.

How does GDPR interact with IVDR work?

Where software processes personal data, both apply. We map controls so one set of evidence supports both sets of obligations.

Can Medysec help prepare for Notified Body questions?

Yes. Medysec can review the cybersecurity evidence package, identify gaps, strengthen supporting documentation, and help prepare technical responses for conformity-assessment discussions.

EU IVDR Compliance

EU IVDR Cybersecurity Compliance for In Vitro Diagnostic Device Manufacturers

We support applicable IVDR cybersecurity requirements for connected IVD instruments, software, and supporting systems.

Talk to a IVDR Cybersecurity Expert See IVDR Security Scope

Medysec Deliverables

What IVDR Cybersecurity Deliverables Does We Provide for IVD Manufacturers

We turn applicable IVDR cybersecurity expectations into structured assessments, technical evidence, security documentation, testing results, and lifecycle support.

Cybersecurity Risk Assessment
Cybersecurity Risk Management Documentation
Threat Modeling Report
Security Architecture Documentation
Cybersecurity Requirements Specification
Cybersecurity Controls & Traceability Matrix
Software & Cybersecurity Documentation
SBOM & Software Supply Chain Security Documentation
Vulnerability Assessment Report
Security Testing & Verification/Validation Report
Penetration Testing Report
Penetration Testing Retesting Report
Cybersecurity Incident Management & Vulnerability Handling Procedure
Cybersecurity Post-Market Surveillance & Monitoring Documentation
Cybersecurity Labeling / Security Information for Users

Our Compliance Process

Our EU IVDR Compliance Process Workflow

We assess the IVD, its software, interfaces, dependencies, and risks, then connect that work to the technical documentation.

01
IVDR Scope & Cybersecurity Assessment
Assess the IVD, intended purpose, software, connectivity, architecture, target market, and applicable IVDR cybersecurity requirements.
02
Architecture & Attack Surface Assessment
Review architecture, interfaces, data flows, communications, cloud services, dependencies, and external attack surfaces.
03
Threat Modeling & Cybersecurity Risk Assessment
Identify assets, threats, vulnerabilities, attack paths, impacts, controls, and residual cybersecurity risks.

Standards & Framework

Standards and Frameworks We Follow

Our work is informed by the IVDR requirements and guidance relevant to your IVD and cybersecurity evidence.

Regulation (EU) 2017/746
IVDR Annex I
IVDR Annex II
IVDR Annex III
IVDR Annex XIII
MDCG 2020-16 rev.5
MDCG 2024-11
MDCG 2022-9 rev.1
MDCG 2020-1
MDCG 2019-11 rev.1
MDCG 2019-16 rev.1
MDCG 2025-10
MDCG 2019-7 rev.1

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

EU IVDR Case Studies

Cybersecurity Evidence for IVD Market Access

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.

Read Case Study

Healthcare platform threat-modeling case study illustration

Building a practical threat-modeling process for a healthcare platform

A healthcare platform engagement that clarified security ownership, mapped critical attack paths, and improved evidence for release decisions.

Read Case Study

Patient-facing health application cloud security case study illustration

Securing cloud services behind a patient-facing health application

A practical cloud security review that helped a patient-facing product prioritise its most important configuration and access-control improvements.

Read Case Study

EU IVDR FAQ

Frequently Asked Questions

Yes. IVDR covers software that qualifies as an IVD, including software driving or influencing diagnostic functions, subject to its intended purpose and classification.