Your Partner in Medical Device Cybersecurity Compliance
Helping innovators meet FDA and global cybersecurity requirements with confidence.
Because patient safety and compliance can’t wait, Rosmir Consulting LLC specializes in cybersecurity and regulatory readiness for medical devices and healthcare software. Our mission: help you navigate complex regulations, implement secure-by-design practices, and accelerate your path to market—from pre-market design through post-market surveillance.
What We Do
We provide expert advisory services to help you:
- Navigate complex regulatory frameworks
- Implement secure-by-design practices throughout the product lifecycle
- Prepare for FDA, EU MDR/IVDR, and Health Canada cybersecurity requirements
Compliance Expertise
Our guidance ensures alignment with international standards and expectations, including:
- FDA Cybersecurity Guidance for Medical Devices
- Health Canada cybersecurity requirements
- EU MDR / IVDR cybersecurity expectations
- ISO 13485, IEC 62304, ISO/IEC 27001, and IMDRF cybersecurity principles
We help you address cybersecurity threats, manage risk, and prepare for regulatory scrutiny.
Rosmir Consulting does not manufacture or distribute regulated products, nor do we make any claims related to device safety or efficacy. Our services are strictly advisory, ensuring independence and compliance.
Founder: Dr. Stepan Baranov
Stepan Baranov, Ph.D., is the founder and lead consultant at Rosmir Consulting LLC. A recognized expert in medical device cybersecurity, he brings over 15 years of experience spanning software engineering, secure product development, and regulatory compliance leadership.
Industry Experience
Dr. Baranov has held key roles at leading healthcare and life sciences organizations, including:
- BD (Becton, Dickinson and Company) — Led product security initiatives at the business unit level, building secure software platforms for medical devices and connected health solutions.
- Leica Microsystems — Developed advanced imaging and blood flow analysis software for clinical applications.
- Academic Research — Contributed to OCT medical device R&D at the University of Houston and the University of Texas at Austin.
Core Competencies
- Secure Software Architecture (SaaS, cloud, and embedded systems)
- Medical Device Risk Management & Threat Modeling
- Regulatory Compliance: FDA, HIPAA, MDR, ISO 13485, IEC 62304, UL 2900
- Identity & Access Management, Secure SDLC, Vulnerability Analysis
- Leadership: Agile/Scrum, Global Collaboration, Vendor Oversight
Dr. Baranov holds a Ph.D. and M.S. from Moscow State University. He is passionate about helping companies build safer, more secure medical technologies—with the confidence to scale globally.
Work with Us
At Rosmir Consulting, we partner with your engineering and compliance teams to deliver practical, regulatory-aligned cybersecurity solutions. Our approach is collaborative, transparent, and focused on helping you bring secure, compliant medical technologies to market faster.
Whether you’re developing a connected medical device or a digital health platform, we provide the expertise you need for:
- Security strategy and architecture design
- Regulatory documentation and submission readiness
- Design validation and risk management
Let’s build safer, more secure healthcare technologies together.
Schedule a Consultation →