Quality Assurance

Applied Spectral Imaging (ASI) - Quality is in Our Genes

ASI’s Quality Management System (QMS) complies with the requirements of ISO 13485, the inline standard requirement for medical devices.  This standard represents the requirements for a comprehensive quality management system for the design, manufacture, export and sales of various medical devices. ASI’s QMS is also harmonized with the ISO 9001 quality standard.

Click here to read ASI’s Quality Policy

ASI’s activities are compliant with ISO 13485 when it comes to supply, development, operation and maintenance of computer software and related support services.

The continued approval of ASI’s Quality Management System highlights our ongoing commitment to excellence in all of the above areas. All of our software and hardware products are designed, developed, produced, installed and serviced are in compliance with QMS requirements of ISO 9001, and ISO 13485 certified by Intertek, the UK based leading provider of laboratory testing, research, inspection and consulting services for global industry, markets and institutions.

ASI conforms to ISO 9001 and ISO 13485 quality standards for medical devices and is fully conversant with HIPAA, Health Insurance Portability and Accountability Act requirements for patient privacy and security.

ASI Certifications

  • ISO 9001
  • ISO 13485 Medical Devices - Quality Management Systems
  • ISO 13485 CMDCAS Medical Devices - Quality Management Systems

ASI conforms to the 21 CFR 820 for compliance to US code of federal regulation quality systems, and IVDD 98/79/EC of the European In-Vitro Diagnostic MD directive. ASI products comply with RoHS and WEEE directives and therefore bears the CE mark of conformity.

Regulatory Assurance

Applied Spectral Imaging (ASI) makes patient care better through microscopy imaging analysis

The GenASIs platforms for genetic and pathology analysis are the foundation of ASI’s offering. With excellent imaging and analysis capabilities, ASI provides a truly state of the art diagnostic aid which integrates with the lab workflow, and encourages reproducible and reliable results. 

In the United States, ASI solutions are cleared by the FDA as an aid for in-vitro diagnostic procedures for the following clinical applications:

  • BandView for karyotyping with real time microscope images from stained metaphases.
  • FISHView - FISHView is intended as an aiding tool for digitally visualizing, processing, enumerating and classifying stained cells and storing FISH multi-dye images.
  • CEP XY for assessing the effectiveness of bone marrow transplantation in opposite-sex transplants.
  • UroVysion designed for microscopic imaging and analysis of chromosomal aberrations using fluorescence in situ hybridization (FISH) in urine specimens from persons suspected of having bladder cancer.
  • ALK, the world’s first and only FDA cleared ALK automated gene scanner used for lung cancer therapy selection.
  • HER2/neu FISH for in-vitro diagnosis as an aid to the cytogeneticist/pathologist in the deletion, classification, and counting of cells of interest in tissue specimens from suspected breast cancer patients.
  • HiPath for assessment in immunohistochemistry stained histologic sections from formalin-fixed, paraffin-embedded normal and neoplastic tissues.

 

GenASIs Applications are FDA cleared for the following GenASIs applications: BandView, FISHView, CEP XY, UroVysion, ALK & HER2/neu FISH and IHC Family for: HER2, ER, PR and Ki67. 

All other products are for research purposes only, not intended for diagnostic or therapeutic use.