Digital medical devices

To certify your medical device software or digital health solution

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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.

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MD101, founding member of The MedTechAlliance, USA