What if we are not sure which requirements apply to our device?

Start with the device, market, data handled, and intended use. These factors help determine which regulatory and compliance requirements need to be addressed.

Can Medysec review our existing compliance documents?

Yes. Medysec can review your current cybersecurity evidence, identify gaps, and explain what needs updating before you begin additional compliance work.

Can you work with our notified body or consultant?

Yes. We provide the technical evidence your consultant or notified body needs, and support you through the questions they raise.

Where does cybersecurity sit in a compliance programme?

Inside risk management and product documentation, which is why it works better as engineering activity than as a paperwork exercise.

Can Medysec help before a regulatory review starts?

Yes. Medysec can review your existing package, identify likely evidence gaps, and help address them before submission or external regulatory review.

Compliance Solutions

Compliance Solutions for Medical Device and Healthcare Requirements

We help medical device manufacturers and healthcare organizations meet the regulatory frameworks that govern connected devices and patient data: FDA, HIPAA, EU MDR, EU IVDR, and CE Marking.

Talk to a Compliance Specialist

Regulatory & Compliance Scope

Navigate the Requirements That Apply to Your Product

Explore the regulatory and compliance areas relevant to medical devices, diagnostic technologies, healthcare data, and connected MedTech products.

FDA

Cybersecurity documentation for 510(k), De Novo, and PMA submissions.

See FDA Compliance

HIPAA

Security safeguards for protected health information.

See HIPAA Compliance

EU MDR

Cybersecurity documentation for EU medical device market access.

See EU MDR Compliance

EU IVDR

Cybersecurity for in-vitro diagnostic devices sold in the EU.

See EU IVDR Compliance

CE Mark

Conformity support tied to EU MDR and IVDR cybersecurity requirements.

See CE Mark Compliance

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 are 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

Case Studies

Real-World Case Studies

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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 client's FDA 510(k) documentation.

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