ProDUCT DEVELOPMENT and Quality Assurance Services

With over 8 years of experience in the medical device industry including manufacturing, quality assurance, and product development, we specialize in helping medical device companies get their products to market, and keep them on the market.

Our goal is to help get your product to market. We can provide support through all phases of product develoment from proof of concept, design requirements definition (User needs, system design inputs, user interface requirements, hardware specifications, etc), design verification and validation planning and excution, risk management, human factors engineering, design transfer, to commercialization and post market surveillance activities. Our support can range from generating, reviewing, or remediating DHF documentation, to project management support using Agile Methodolgies to expedite project deliverables. 

We aim to ensure your projects can be delivered on time, on budget, while remaining compliant to applicable International standards and regulations (21 CFR 820, ISO 13485, ISO 14971, IEC 62366, HE 75, IEC 60601, IEC 62304, EU Medical Device Directive, EU Medical Device Regulation, etc). Our select team are experienced in the development of complex medical devices including single use disposables, electromechanical equipment, catheter-based devices, and surgical robotics systems for global commercial distribution (NA, EMEA, APAC).