Does MDR require penetration testing?

MDR does not name the activity, but GSPR 17.2 requires demonstrated security, and notified bodies expect test evidence in the technical file.

What if a vulnerability is found before submission?

The manufacturer can assess its risk, apply appropriate remediation, retest the affected component, and retain documented evidence showing how the vulnerability was addressed.

How often should MDR cybersecurity evidence be updated?

Updates depend on product changes, newly identified vulnerabilities, incidents, software releases, and post-market findings that could alter the device's cybersecurity risk profile.

How does the EU Cyber Resilience Act affect devices?

Where a product includes software with digital elements, the CRA adds vulnerability handling, reporting, and support-period obligations alongside MDR.

What does the MDD to MDR transition change?

Cybersecurity moves from implicit to explicit. The technical file has to evidence security rather than describe the intent to address it.

EU MDR Compliance

EU MDR Cybersecurity Compliance for Medical Device Manufacturers

We support EU MDR cybersecurity expectations for connected devices covering Annex I GSPR 17.2, MDCG 2019-16, and the upcoming EU Cyber Resilience Act.

Discuss EU MDR Cybersecurity

Medysec Deliverables

What EU MDR Cybersecurity Deliverables Does We Provide

We build the security evidence needed across risk management, threat modeling, software security, testing, vulnerability management, and postmarket activities.

Security Management Plan
Threat Model
Security Architecture
Security Requirements Specification (SRS)
SBOM (Software Bill of Materials)
Security Verification & Validation Report
Vulnerability Management & Patching Policy
Cybersecurity Risk Assessment
Cybersecurity Risk Management File
Post-Market Cybersecurity Surveillance Process
Incident Handling & Regulatory Reporting Procedure
Cybersecurity Control Catalogue
Cybersecurity Traceability Matrix
Penetration Test (VAPT Report)
Computer Incident Security Incident Management

Our Compliance Process

Our EU MDR Compliance Process Workflow

We connect applicable MDR requirements to product architecture, cybersecurity risks, testing, and the technical record.

01
Discovery & Regulatory Scoping
Assess the device, intended purpose, architecture, connectivity, EU market, documentation, and applicable MDR 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 EU MDR requirements and guidance relevant to your device and cybersecurity evidence.

Regulation (EU) 2017/745
MDR Annex I
MDR Annex II
MDR Annex III
MDCG 2019-16 Rev. 1
MDCG 2019-11 Rev. 1
MDCG 2020-3 Rev. 1
MDCG 2025-10
MDR GSPR

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 MDR Case Studies

Security Evidence for European 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