Simpleware Medical Regulatory Information

Simpleware Medical has CE Marking, FDA 510(k) marketing clearance, and ISO 13485:2016 certification.  

CE Marking Certificate MDR

FDA 510(k) Premarket Notification

ISO 13485:2016 Certificate

Please note that only the Simpleware Medical product is available for the below Uses.

Indications for Use (FDA 510(k))

Simpleware Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended as pre-operative software for diagnostic and surgical planning.

For these purposes, output files can also be used for the fabrication of physical replicas using traditional or additive manufacturing methods. The physical replicas can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications.

The software is intended to be used in conjunction with other diagnostic tools and expert clinical judgment.

For a list of printers cleared for diagnostic 3D printing use, please visit our Point-of-Care (POC) 3D Printing page.

Intended Use (CE Marking)

Simpleware Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. The software is intended to inform clinical management by improving confidence in clinical decision-making and pre-surgical planning through use of patient-specific 3D models (virtual 3D models and 3D printed anatomical models) created from medical imaging. Outputs from the software must be reviewed for clinical suitability by expert clinicians working on specific patient cases.

The general version of Simpleware software is intended only for research purposes. It is intended to be used for visualization, analysis and model generation of a variety of imaging formats, including for biomedical research. However, this version must not be used, and is not intended to be used, for any medical or clinical purpose whatsoever.

Instructions for Use

The Instructions for Use (IFU) for Simpleware Medical is available to download in an electronic format:

• Instructions for Use (Multi-Language)

Minimum requirements for viewing IFU: PDF viewer

Version History: The current release is X-2025.06

Past Instructions for Use:

• W-2024.12 Instructions for Use (Multi-Language)
• V-2024.06 Instructions for Use (Multi-Language)
  

Older IFU records can be provided on request.