Electrical and electromechanical devices
Physical devices whose clinical function is delivered primarily through hardware, mechanics, electronics or controlled energy.
Active devices · treatment equipment · monitoring systemsMedical devices and equipment
Regulatory support for hardware-led medical technologies
Physical medical devices are rarely isolated pieces of hardware. Firmware, sensors, computer interfaces, accessories and supporting software can all affect safety, performance and the regulatory route.
Product profileHardware-led system
Principal clinical functionPhysical medical device
01
Embedded firmware
02
Computer interface
03
Accessories and modules
Every relevant component is assessed within one defined device system.
Product scope
More than purely mechanical, less than software-defined
This category covers devices whose principal function remains physical, even when digital elements support operation, safety, communication or integration into a wider clinical environment.
Devices with embedded firmware
Products that use firmware or limited software for control, display, alarms, calculations or safety-related functions.
Embedded control · displays · alarms · sensorsComputer-connected devices
Equipment that exchanges data with a workstation, application or hospital system and requires verified interfaces and compatibility.
Drivers · data transfer · interoperability · updatesDevice systems and accessories
Configurations combining a principal device with accessories, consumables, connected modules or supporting software.
System boundaries · configurations · compatibilityProduct boundary
The regulatory scope follows the complete system
Simple software does not make the product simple from a compliance perspective. Its influence on essential performance, alarms, data integrity, user decisions and connected equipment must be understood and verified.
System elementRegulatory focus
HardwareSafety, performance and reliability
FirmwareLifecycle control and verification
InterfacesCompatibility and data integrity
ConfigurationValidated combinations and intended use
Regulatory route
A connected route from definition to market
We align product strategy, engineering evidence and regulatory documentation so that the submission reflects the device as it is designed, tested and used.
Product definition
Intended purpose, claims, system boundaries and regulatory qualification.
Classification and route
EU MDR classification and the appropriate US FDA pathway.
Safety and engineering
Risk management, electrical safety, EMC, usability and software controls where applicable.
Verification and evidence
Bench testing, compatibility, performance, clinical evaluation and traceability.
Submission and lifecycle
Technical documentation, authority interaction, change control and post-market activities.
Work with MDRC
Keep the physical device and its digital elements on one regulatory path
We support regulatory strategy, technical documentation, risk management, verification and validation, clinical evaluation, quality systems and post-market compliance for the EU and United States.
Engagement can start with an early concept, a device already in development or an existing technical file that needs a clearer system boundary and submission strategy.
Talk to MDRC
