Simpleware Medical Regulatory Information

Simpleware Medical has been cleared for use as a medical device for the intended uses available below in accordance with the requirements of the U.S. Food & Drug Administration (FDA) 510(k), EEA CE marking, Australian Therapeutic Goods Administration (TGA), and Japanese Pharmaceuticals and Medical Devices Agency (PMDA):  

FDA 510(k) Premarket Notification

CE Marking Certificate MDR

ISO 13485:2016 Certificate

Australian Register of Therapeutic Goods (ARTG)

Japanese PMDA Certified Item List

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

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.

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 CE mark is currently applicable in the following countries only: Austria, Belgium, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Ireland, Luxembourg, Malta, Netherlands, Poland, Slovenia, Spain, Switzerland, and United Kingdom.

The Instructions for Use (IFU) for all supported versions of Simpleware Medical are available to download in an electronic format from:

Synopsys SolvNetPlus - 'Download Here' (including applicable translations)

Minimum requirements for viewing the IFU: PDF viewer

Older IFU records can be provided on request.