FDA Premarket Cybersecurity
Build the threat, risk, software, testing, and supporting evidence required for the applicable FDA submission.
Global MedTech Cybersecurity
Cybersecurity for MedTech and Healthcare
We provide dedicated MedTech cybersecurity and compliance solutions to help you navigate strict regulatory requirements, pass reviewer checks, and protect patient safety.
Trusted by Leading Medical Device Companies
Our services
Medical Device Cybersecurity Services
From FDA cybersecurity and regulatory support to hands-on penetration testing, Medysec covers every service a medical device or MedTech manufacturer actually needs.
FDA Deficiency Response
Direct, fixed-fee support closing FDA cybersecurity deficiency letters inside reviewer timelines.
SaMD Cybersecurity
Security assessment and documentation built for software as a medical device, not adapted from generic app testing.
FDA Postmarket Cybersecurity
Maintain visibility into vulnerabilities, assess product impact, and support remediation throughout the device lifecycle.
Medical Device Penetration Testing
Test hardware interfaces, firmware, communications, and connected product surfaces for exploitable weaknesses.
Application Penetration Testing
Healthcare web app, mobile companion app, EHR integration. OWASP ASVS L2/L3, NIST SP 800-53, manual + automated blend.
Compliance & Regulatory
Navigate Global MedTech Cybersecurity Requirements
Medysec maps cybersecurity evidence to the regulatory frameworks that govern connected medical devices, wherever they ship.
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 ComplianceOur Track Record
Proven By Numbers
Our track record reflects deep medical device cybersecurity expertise and the trust clients place in our team.
- 0+
- Trusted Clients Globally
- 0+
- Device Security Assessments
- 0+
- Compliance Achieved
- 0+
- Medical Devices Tested
Ready to Secure Your Medical Device?
Tell us what you are working on and we will give you a straight read on scope, timeline, and cost.
Book A Call
MedTech Security Challenges
Why Medical Device Security Is Different
A medical device is not just another connected system. A weakness in a connected device doesn't stop at data, it can reach the device itself and the person relying on it.
Patient Safety
Unsecured medical devices directly risk patient safety.
Regulatory Pressure
Manufacturers must address cybersecurity throughout product life cycles.
Connected Devices
Connected multi-vendor software increases medical device attack risks.
Supply Chain & Dependencies
Unverified third-party components widen medical device attack surfaces.
Legacy Device Challenges
Old medical devices often run unpatchable, outdated software.
Evolving Threats
Ransomware, unpatched components, and weak integrations increase device risks.
Why Medysec
Why Medical Device Companies Choose Medysec
Medysec brings together healthcare specialization, offensive-security capability, medical-device understanding, and practical support for security and regulatory teams.
MedTech Specialization
Medysec focuses exclusively on connected MedTech.
Compliance & Regulatory Depth
We comply with regulatory frameworks from FDA to MDR requirements.
Offensive Security Depth
We find attack paths across devices, applications, and cloud.
End-to-End Support
We support medical devices throughout their entire lifecycle.
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
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.
Read Case Study
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
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 StudyGet In Touch
Get a tailored cybersecurity quote.
Secure your medical technology with confidence.
Whether you are preparing any regulation or standards submission, testing a connected device, or assessing risk across a MedTech platform, we can start with a scoping call.
- 0+
- Trusted Clients Globally
- 0+
- Years in Business
- 0+
- Device Security Assessments
- 0+
- Compliance Achieved
- 0+
- Medical Devices Tested
