Develop innovative, intuitive medical device control software using the latest technologies and methodologies
Kennovation helps in delivering medical imaging and device software solutions for diagnostic, imaging, biomedical, and clinical projects. We use the AAMI-TIR-45 methodology to ensure ISO, FDA, and HIPPA compliance.
Agile Development Process while ensuring various ISO Standards – QMS-13485, SDLC-62304, Risk-14971 – compliance
510(k) Premarket Notification Clearances, Premarket Approvals(PMA), Medical Device Safety for various different classes of medical devices
ePHI(Electronic Protected Health Information) support via inbuilt encryption and anonymization. Secured PHI sharing via DICOM, HL7 Integration
OUTCOME
FOCUS ONPATIENT OUTCOMEIt is critical to design medical equipment with a focus on patient outcomes. This approach ensures a higher rate of acceptance for the product by the medical community.
INTEGRATION
CONNECT WITHHOSPITAL NETWORKSMedical Devices need to integrate with hospital networks using HL7 and DICOM with HIPPA compliant encryption technologies. This provides integrated view of the patient records with scheduling and billing information
USABILITY
EXCEPTIONALINTUITIVE EXPERIENCEEase of use is extremely important for medical devices. Intuitive user interfaces make it easier for doctors and medical technicians to operate the devices, enabling them to focus more on the patients
COMPLIANCE
MEET ALL THENECESSARY STANDARDSMedical Industry requires adherence to various stringent medical standards. Kennovation follows ISO/FDA complaint design, development, and QMS procedures to develop a product that meets all of the necessary certifications.