The medical device arena is ever expanding and evolving, along with the stringent regulations that guide medical device product development. The products in a medical device firm’s 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 goes beyond developing digital products; we help clients develop multi-generational, multi-geographic portfolios. We work closely with clients to understand their market and business challenges and ensure their success. With a focus on the 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.

Our Expertise



Develop data strategies for your device, customers and patients.



Develop secure, scalable, and compliant digital solutions.



Design elegant and personalized experiences for clinical users and patients.



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 maintenance, 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, and 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.