Digital medical devices

Dedicated experts, a customized solution

Digital medical devices, whether embedded as “Software in Medical Device” (SiMD) or standalone “Software as Medical Device” (SaMD) devices, must meet IEC 62304, IEC 82304-1 and IEC 6601-1 requirements, as well as the specific requirements of FDA guidelines.

MD101 can assist you to register your devices and obtain CE-mark and FDA clearance:

• Assistance in compiling software documentation.
• Determination and justification of the “documentation level” according to the FDA guide for software.
• Determination and justification of software safety class according to IEC 62304.
• Support in carrying out software risk analyses.
• Support for the implementation of software development and maintenance procedures, in compliance with IEC 62304 and IEC 82304-1 requirements.
• Audit of software technical documentation in line with CE marking and FDA requirements.