Medical Device Focus
Security built around your device, architecture, interfaces, and lifecycle.
About Medysec
We are MedTech Cybersecurity Company
We bring established cybersecurity expertise into a dedicated practice built around medical devices, connected MedTech, and the regulatory work that comes with them.
Why Medysec Exists
The Story Behind Medysec
Medical device cybersecurity requires more than technical testing. It requires people who understand how devices are designed, how security risks affect the product, and how those risks translate into regulatory evidence. Medysec brings those disciplines together in one specialist practice.
Technical Depth
Deep technical testing across applications, firmware, hardware, APIs, and cloud.
Regulatory & Compliance Expertise
Security work aligned with applicable medical device requirements, standards and compliances.
Experienced Security Specialists
Experienced specialists stay directly involved throughout every engagement.
Our Mission
Our mission is to secure connected medical devices through named-team, fixed-fee engagements that hold up under FDA reviewer scrutiny, HIPAA auditor scrutiny, and EU Notified Body scrutiny, wherever the device ships.
Our Vision
Our vision is a market where every connected device ships with a reviewed threat model, tested security controls, and a vulnerability process that keeps working long after clearance.
Our Purpose
Our purpose is to give medical device manufacturers a security partner who understands the engineering and the regulatory stakes together, so security work strengthens a submission instead of slowing it down.
The People Behind Medysec
Meet our Medical Device Cybersecurity Experts
Our team combines cybersecurity practitioners, medical device security specialists, and people who have worked inside regulated product and quality organisations.
Chandan Kumar Sahoo
Founder & CEO, Qualysec
10+ years in healthcare cybersecurity, medical device security, and regulatory compliance. Former advisor to FDA and industry working groups.
Pabitra Kumar Sahoo
Co-Founder & COO at Qualysec
Specialist in medical device security, FDA submissions, and regulatory strategy, with 15+ years in MedTech and healthcare cybersecurity.
Methodology & Standards
FDA510(k)De NovoPMASection 524BeSTARAAMI TIR57IEC 62304IEC 81001-5-1ISO 14971ISO 13485SBOMNIST CSF 2.0HITRUST CSF v11HIPAA
Device We Secure
Securing Every Device Across Your MedTech Ecosystem
Every category below is something we’ve taken through FDA cybersecurity review.
Patient Monitors
Infusion Pumps
Imaging Devices
Diagnostic Equipment
Wearables
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
Ready to Scope Your Medical Device Cybersecurity Engagement?
Book a 30-minute briefing with a named Medysec healthcare cybersecurity analyst, or run our free 5-minute readiness check first. NDA on request, no sales handoff.