Wherever you are in your product development lifecycle,
Sterling can help.
Partner with a highly-experienced, focused, and flexible group of experts who will help see your medical device project through to completion the right way.
Our team of medical device engineers are ready to help at any point in your development lifecycle. By giving proper attention to clinical, regulatory, and engineering constraints, we make sure that the overall system and subsystem requirements necessary for FDA/CE approvals are met.
Sterling Medical Devices is ISO 13485 certified and we work with medical device companies throughout the entire software development lifecycle using state-of-the-art tools and equipment. Our team will help you to align your medical device software development efforts with FDA expectations and gain faster regulatory approvals.
Every process of the medical device lifecycle requires careful attention to risk: from software engineering planning to implementation to testing to final reporting. A rigorous medical device risk management process will ensure project development time and costs stay low. Sterling Medical Devices has over 15 years of experience having worked on over 400 projects. This experience in risk management helps medical devices get through the FDA & CE approval process easier and to market faster.
February 18, 2021
September 8, 2020