Client Success Story
Advancing Healthcare with Wireless Cystoscope Design
Company
Medical Device Company
At the forefront of medical device innovation, Zealogics showcases extensive expertise in transforming the landscape of endoscopic procedures. In collaboration with a medical device company, our mechanical engineering prowess drove the creation of a revolutionary wireless cystoscope. This encompassed comprehensive product design, meticulous adherence to regulatory standards, and rigorous testing protocols. The outcome stands as a groundbreaking wireless cystoscope, poised to elevate medical procedures, and enhance patient care, marking a significant stride in the healthcare industry. Explore our case study to delve into this transformative journey.
Client Challenge
A forward-thinking medical device company set out to pioneer an innovative wireless cystoscope, envisioning a transformative impact on endoscopic procedures. Their objective posed a significant challenge: designing a compact, user-friendly device in strict compliance with FDA and other regulatory standards. To achieve this vision, the client required adeptness in various domains, including product design, detailed engineering, DMR creation, medical device prototyping, rigorous testing, and comprehensive FDA regulatory compliance support. This case study elucidates the journey taken to materialize their concept into a market-ready reality.
Ideal Solution Proposed
Our adept mechanical engineering team undertook a comprehensive approach to address the wireless cystoscope design requirements. Commencing with meticulous product design, our focus centered on achieving compactness and user-friendly ergonomics, prioritizing both patient comfort and seamless usability for medical professionals. The detailed engineering phase involved precise component selection and seamless integration to ensure optimal functionality. We meticulously curated a robust Device Master Record (DMR) encompassing intricate specifications, precise drawings, and rigorous testing protocols. The subsequent prototypes underwent stringent testing, including biocompatibility assessment, durability evaluations, and meticulous functional verification, all meticulously executed to meet the exacting standards set by the FDA. Throughout this journey, our dedicated regulatory experts provided unwavering support to the client, navigating the complex FDA approval process seamlessly, thus ensuring compliance and facilitating swift market entry. This all-encompassing solution culminated in the creation of a cutting-edge wireless cystoscope, significantly elevating medical procedures and advancing the landscape of patient care.