Our Commitment to Quality
Myrava is committed to delivering innovative, high-quality products and services that meet or exceed customer expectations. Our quality management approach is centered on:
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Continuously improving our products, processes, and services to achieve our quality objectives
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Understanding customer requirements and delivering solutions that meet customer needs
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Encouraging shared responsibility among team members for the quality of our products and services
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Maintaining the effectiveness of our quality management system
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Complying with all applicable regulatory requirements
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To this point, Myrava maintains certification to ISO 13485:2016, Medical Devices – Quality Management Systems – Requirements for Regulatory Purpose.Â
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Quality and Regulatory Resources
Access important regulatory information, clinical-use guidance, scanning protocols, and product specifications for Myrava’s products.
3D Bolus Regulatory Information
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Bolus must be verified and approved by the United States licensed radiation therapy professional prior to use on a patient.
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Boluses have been evaluated for 6 MV photons and 6 and 9 MeV electrons.
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Myrava manufactures patient-specific medical devices within an ISO 13485 compliant quality system
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HIPAA compliant portal for secure DICOM and RT structure file submission
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 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.