Singular Health Group Secures Global Certification for 3Dicom Medical Software Development

Singular Health Group, an Australian medtech company, has recently obtained global certification for its 3Dicom diagnostic medical software. This certification is a crucial prerequisite for regulatory approval and distribution of medical devices in international markets. By retaining the ISO13485 certification, Singular Health Group demonstrates its commitment to maintaining high-quality standards and adherence to global regulatory requirements.

The ISO13485 certification ensures that Singular Health Group’s 3Dicom software complies with the regulatory and quality standards of various medical device regulatory bodies, including Health Canada, the Therapeutic Goods Administration in Australia, and the United States Food and Drug Administration (FDA). This certification is essential for the registration and distribution of Class II and higher medical devices.

Singular Health Group’s 3Dicom software enables medical practitioners to convert 2D MRI, CT, and PET scans into immersive 3D images, enhancing their understanding of a patient’s medical conditions and aiding in surgical planning. The software is available in three categories: 3Dicom MD for diagnosis and treatment, 3Dicom Patient for storing medical records, and 3Dicom R&D for educational purposes.

In addition to obtaining regulatory clearance certification, Singular Health Group has relocated its software development activities to Bibra Lake and successfully passed its annual surveillance audit conducted by the British Standards Institute (BSI). This audit highlights the company’s commitment to maintaining quality and risk management in the development of their diagnostic medical software.

The recent achievements of Singular Health Group include securing a purchase order for their 3Dicom technology from Roseman University in Nevada and receiving its first enterprise order in the US for 3Dicom licenses purchased by Techworks 4 Good on behalf of American veterans. These milestones demonstrate the growing adoption and recognition of 3Dicom as a valuable tool in medical education and patient care.

With its global certification and continued advancements in the field of diagnostic medical software, Singular Health Group is well-positioned to expand its presence in international markets and contribute to the improvement of medical practices worldwide.

Frequently Asked Questions (FAQ)

Q: What certification has Singular Health Group obtained for its 3Dicom diagnostic medical software?
A: Singular Health Group has obtained the ISO13485 certification.

Q: Why is the ISO13485 certification important?
A: The ISO13485 certification ensures that the 3Dicom software complies with regulatory and quality standards required for the registration and distribution of Class II and higher medical devices.

Q: What can the 3Dicom software do?
A: The 3Dicom software can convert 2D MRI, CT, and PET scans into immersive 3D images, enhancing medical practitioners’ understanding of patients’ medical conditions and aiding in surgical planning.

Q: What are the three categories of the 3Dicom software?
A: The software is available in three categories: 3Dicom MD for diagnosis and treatment, 3Dicom Patient for storing medical records, and 3Dicom R&D for educational purposes.

Q: Where has Singular Health Group relocated its software development activities?
A: Singular Health Group has relocated its software development activities to Bibra Lake.

Q: What milestone has Singular Health Group achieved in the US?
A: Singular Health Group has received its first enterprise order in the US for 3Dicom licenses purchased by Techworks 4 Good on behalf of American veterans.

Q: How has Singular Health Group demonstrated its commitment to maintaining quality?
A: Singular Health Group has successfully passed its annual surveillance audit conducted by the British Standards Institute (BSI).

Definitions:
– Medtech: Medical technology, referring to devices and technologies used in the field of healthcare.
– ISO13485 certification: A certification that ensures compliance with regulatory and quality standards for medical devices.
– Regulatory approval: Approval granted by regulatory bodies for the sale and distribution of medical devices.
– MRI: Magnetic Resonance Imaging, a medical imaging technique to visualize internal structures of the body.
– CT: Computed Tomography, a medical imaging technique that uses X-rays to create detailed cross-sectional images of the body.
– PET: Positron Emission Tomography, a medical imaging technique that measures metabolic activity in the body to detect diseases.

Suggested related links:
Singular Health Group website
International Organization for Standardization
Health Canada
Therapeutic Goods Administration (Australia)
United States Food and Drug Administration (FDA)