For Medical Industry
Medical Industry
We combine design-thinking and agile methodology to develop innovative, intuitive medical device control software using the latest technologies. Kennovation delivers medical imaging and device software for diagnostic, imaging, biomedical, and clinical projects.
Partner With UsKey Capabilities
We employ AAMI-TIR-45 methodology to ensure compliance with ISO, FDA, and HIPAA standards across all our medical device and healthcare technology engagements.
QMS Compliance
Agile development process ensuring ISO 13485 (QMS), ISO 62304 (SDLC), and ISO 14971 (Risk Management) compliance
Medical Devices
FDA 510(k) Premarket Notification Clearances, Premarket Approvals (PMA), and medical device safety across all device classes
Security & Privacy
ePHI (Electronic Protected Health Information) via encryption and anonymization, secured PHI sharing via DICOM and HL7 integration
Strategic Focus Areas
Four critical dimensions guide every medical technology engagement we undertake.
Outcome
It 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. We prioritize clinical effectiveness and patient safety in every design decision.
Integration
Medical devices connect with hospital networks using HL7 and DICOM standards with HIPAA-compliant encryption, providing integrated patient records along with scheduling and billing information for seamless clinical workflows.
Usability
Ease 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 their patients rather than struggling with technology.
Compliance
The medical industry requires adherence to various stringent standards. Kennovation follows ISO/FDA-compliant design, development, and QMS procedures to develop products that meet all necessary certifications and regulatory requirements.
Certifications & Standards
Our expertise spans the full spectrum of medical device regulatory standards and certifications.
ISO 13485
Quality Management Systems
ISO 62304
Software Lifecycle
ISO 14971
Risk Management
FDA
510(k) & PMA
HIPAA
ePHI Protection
DICOM
Medical Imaging
HL7
Health Data Exchange
AAMI TIR-45
Agile Methodology
Partner With Us for Medical Innovation
Whether you're developing a new medical device, modernizing legacy systems, or navigating regulatory compliance, our team has the expertise to deliver results.