The medical devices arena is ever expanding and evolving, along with stringent regulations that guide medical device product development. Products in a medical device firms’ portfolio must be smart, deliver value and meet clinical needs. EZEN's team has over 30 years of experience delivering innovative, patient centric digital design solutions
Our team of designers, engineers, quality, regulatory and compliance engineers,and professionals go beyond developing digital products; we help clients develop multi-generational, multi geographical portfolios. We work closely with clients to understand their market and business challenges to ensure their success. With a focus on development of different classes of medical devices, we have the capabilities to bring your medical device from concept to launch. ISO 13485:2016 Certified, our experience and expertise in navigating guidelines allows us to focus on human-centered design throughout the digital development process.
EZEN starts with products, data, and users to create digital experiences. Digital products are by their nature iterative and evolutionary. We deliver innovative solutions today that evolve to be relevant in the future
Develop data strategies for your device, customers and patients.
Design elegant and personalized experiences for clinical users and patients.
Develop secure, scalable and compliant digital solutions.
EZEN prepares its clients to optimize their digital investments: employ compliant hybrid-agile methods, honor global privacy requirements, certify ongoing interoperability and support global use.
Our Technical Experience:
End-to-end core and next-gen technology solutions including Cloud, data management, digital product engineering, modernization and sustenance, AI/ML engineering, Mobility and UI/UX solutions
Extensive interoperability expertise – around EMR, imaging, medical devices,IoMT, labs and other health IT systems, across all healthcare standards (HL7, FHIR, DICOM, EDI, CDA) and a variety of integration methods to enhance care coordination, patient experience and regulatory compliance and reporting
Accelerated digital healthcare solutions for remote monitoring, telehealth, AR/VR based imaging solutions, SaaMD etc
State-of-the-art RPA/AI/ML based automation frameworks, MLOps and DevOps processes to improve efficiencies across the product life cycle
Deep healthcare consulting capabilities, backed by strong thought leadership and vertical-aligned experts with in-depth understanding of MedTech systems, workflows, regulatory and quality compliances (HIPAA, GDPR, CMS, ONC, FDA, ISO) and public health domain