Compliance
Understanding IEC 60601-1-2:2024 EMC Requirements
A comprehensive guide to the latest electromagnetic compatibility standard updates and their impact on medical device design.
January 15, 2026
ReadMEDICAL-GRADE HMI PLATFORM
One Qualification. Unlimited Medical Devices.
MedMI provides a pre-qualified, reusable HMI and compute platform that eliminates certification bottlenecks and accelerates time-to-market for medical device manufacturers.
IEC 60601-1 Pre-Qualified
6x
Faster Certification
vs. custom HMI development
SCROLL
The Challenge
HMI Has Become a Cost & Compliance Bottleneck
Across the medical device industry, HMI hardware is repeatedly designed, integrated, and certified for each product—despite offering minimal differentiation.
20-35%
BOM Concentration
of device BOM concentrated in HMI subsystems, making it a significant cost driver
100%
Repeated Testing
IEC 60601 / EMC testing repeated for every SKU, regardless of similarities
12-18
Months Timeline
average certification timeline per product, delaying market entry
0%
BOM Cost Impact
0mo
Avg. Certification
0%
Timeline Overruns
0x
Cost Multiplier
The Solution
A Standardized, Medical-Grade HMI Platform
Create a centrally qualified HMI subsystem that OEMs integrate as a proven component—dramatically reducing redesign and recertification effort.
Commercial off-the-shelf embedded platforms (SoMs, panels)
Centrally qualified to IEC 60601, IEC 62304 framework
Software-customizable per application
Explicitly decoupled from sensing and therapy logic
Aggregated volume pricing across OEM ecosystem
This IS
- A horizontal infrastructure platform
- A qualified hardware + OS + middleware stack
- A compliance and volume-aggregation play
This IS NOT
- A clinical product
- An application software business
- A competitor to OEM devices
Plug & Play
Ready to integrate
Compliance Baseline
Pre-Qualified to Medical Standards
Our platform is qualified to the essential medical device standards, reducing your certification burden and accelerating market entry.
IEC 60601-1
Medical Electrical Equipment
Safety and essential performance requirements for medical electrical equipment
IEC 60601-1-2
Electromagnetic Compatibility
EMC immunity and emissions compliance for medical devices
IEC 62366
Usability Engineering
Application of usability engineering to medical devices
IEC 62304
Medical Device Software
Software lifecycle processes with segregation templates
FDA Cybersecurity
Premarket Guidance
Aligned with FDA cybersecurity expectations and requirements
MDR 2017/745
EU Medical Device Regulation
General Safety and Performance Requirements for EU market
All certifications available for review under NDA
Platform Specifications
Built for Medical Device Integration
Display Sizes7-10", 10-15", 15-22" touch panels
Operating SystemsLinux (Yocto/Buildroot), Android
ProcessorARM-based SoMs (i.MX8, RK3588)
Memory2-8GB LPDDR4, 16-64GB eMMC
ConnectivityEthernet, WiFi, Bluetooth, USB, CAN
Isolation4kV medical-grade isolation
Temperature0°C to 50°C operating
SoftwareQt, Flutter, Web runtime support
Linux/Android
ARM SoM
Benefits
Transform Your Medical Device Development
MedMI delivers measurable improvements across cost, time, and risk dimensions for medical device manufacturers.
Up to 30%
savings
Lower BOM Costs
Aggregated volumes across OEM ecosystem deliver significant component cost reductions
6-9 months
faster
Faster Time-to-Market
Eliminate repeated certification cycles and accelerate product launches
99.7%
first-pass success
Reduced Risk
Proven, qualified platform reduces regulatory rework and certification risk
Volume
aggregation
Sourcing Leverage
Benefit from collective purchasing power and long-term supply agreements
Multi-product
reuse
Platform Asset
Create reusable internal platform that compounds value across product lines
Long-term
value
High Switching Costs
Once embedded in DHFs, creates long-term defensibility and customer retention
Insights
View All ArticlesLatest from MedMI
Strategy
Reducing Time-to-Market with Pre-Qualified Platforms
How medical device OEMs are leveraging qualified subsystems to accelerate certification and reduce regulatory risk.
January 8, 2026
Read
Technical
Software Segregation in Medical Devices: IEC 62304 Best Practices
Implementing effective software segregation strategies to meet safety classification requirements.
December 28, 2025
Read
Industry
The Economics of HMI Standardization in MedTech
Analysis of cost structures and savings opportunities from platform-based HMI development approaches.
December 15, 2025
Read
Security
Cybersecurity Considerations for Connected Medical HMIs
Addressing FDA and MDR cybersecurity requirements in modern medical device interfaces.
December 5, 2025
Read
Regulatory
From Custom to Platform: A Regulatory Perspective
How regulatory bodies view pre-qualified subsystems and platform-based device development.
November 28, 2025
ReadReady to Accelerate Your Medical Device Development?
Schedule a consultation with our technical team to discuss how MedMI can reduce your certification timeline and BOM costs.