Regulatory & Compliance Information
Myrava is committed to providing innovative high-quality products and services that meet or exceed customer expectations, including:Â
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Focus on continuous improvement of our products, processes and services, to meet our quality objectives Â
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Understanding the customer’s requirements and meeting their needsÂ
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Shared involvement of all team members in the delivery of quality products and services, and maintaining the effectiveness of our quality management systemÂ
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Meeting all current applicable regulatory requirementsÂ
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To this point, Myrava maintains certification to ISO 13485:2016, Medical Devices – Quality Management Systems – Requirements for Regulatory Purpose. View ISO 13485:2016 certificate >
Anatomic Model Regulatory InformationÂ
Myrava Anatomic Models are intended as physical replicas of patient anatomy to be used for diagnostic purposes in the fields of craniomaxillofacial, orthopedic, cardiovascular, neurological, gastrointestinal, genitourinary, and breast applications. The Anatomic Models are based on DICOM imaging information from a medical scanner and output files from FDA cleared software intended for the creation and output of digital files suitable for the fabrication of physical replicas. The models should be used in conjunction with other diagnostic tools and expert clinical judgement.Â
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The accuracy of the Anatomic Model to patient anatomy is determined largely by the quality of the medical imaging data. Â It is recommended that users consult the following Scanning Protocols for best results:
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The following information describes the supported printers, materials, applications, and imaging input for Ricoh 3D Anatomic Models:Â
1.Thin-walled anatomy available in lower-durometer materials with Shore A Hardness of 95 or greater.
2.Technology is single material. Therefore, it is not suitable for models in which distinction between fully/partially encapsulated tissue and surrounding tissue and/or bone is desired.