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Quality & Regulatory

Our quality management system is certified to ISO 13485:2016 for the design, development and manufacture of Active Implanted Medical Devices

Design of Implanted Medical Devices and Components

Clients are able to leverage Med-Ally's design and development resources to tap into decades of experience in order to mitigate regulatory, engineering and assembly risks thus speed up the design process. Med-Ally has contributed to the design of many medical devices for a range of interventional therapies using Implantable Pulse Generators (IPGs) and supporting systems

Prototype Development and Assembly

Our team has instituted novel processes and procedures that are effective in providing consistent results to speed up prototype development. We rely on a mix of high speed and precision robotics to exacting hand assemblies and IPC qualified soldering techniques for exacting prototypes to final product ready for clinical work 

Implanted Medical Device and Component Manufacturing

The Med-Ally facility is extensively capitalized to provide customers with manufacturing solutions for IPG based Class III medical implants. Our commitment to quality and continuous improvement ensures reliable, repeatable outcomes for the highest in quality and cost effective final products. Using a fixed cost approach, Med-Ally strives to preserve our partnered client’s precious resources for a predictable, budget friendly pathway using disciplined fiscal management all the way thru to development completion

Documentation and Project Management

Full Design History File (DHF) documentation is provided as well as professional project management