Med Ally

This company designs, develops, and manufactures active implantable medical device systems. Their devices are used in various medical therapies, including chronic pain management, urinary incontinence, sleep apnea, Tinnitus, and deep brain stimulation.

Updated 2 months ago

Funding

Funding not disclosed

Funding rounds are not available yet.

Founders

Founder details are not available yet.

Product

Problem

Developing active implantable medical devices (AIMDs) is complex, requiring specialized expertise in design, manufacturing, and regulatory compliance. Companies often face challenges in navigating the stringent requirements of FDA 21CFR820 and ISO 13485:2016, as well as managing the risks associated with AIMDs as outlined in ISO 14971.

Solution

Med-Ally provides comprehensive services for the design, development, and manufacturing of active implantable medical devices and their components. The company leverages its VersaStim neuromodulation technology platform, which can be adapted for various medical therapies, including chronic pain management, incontinence, and neurological disorders. Med-Ally offers a vertically integrated facility with a Class 7 cleanroom, advanced manufacturing equipment, and expertise in areas such as hermetic enclosure welding, laser processing, and microelectronics assembly. Their services encompass the entire product lifecycle, from initial concept and design to prototype development, manufacturing, and regulatory submissions.

Target Audience

Med-Ally serves medical device companies seeking a partner for the design, development, and manufacturing of active implantable medical devices, from initial design to regulatory submission and final production.

Features

Design and development of AIMDs, including Implantable Pulse Generators (IPGs) and supporting systems.
VersaStim neuromodulation platform adaptable for various therapies with programmable electronics and telemetry options.
ISO 13485:2016 certified manufacturing processes adhering to FDA 21CFR820 regulations.
Risk management in compliance with ISO 14971, ensuring patient safety and device efficacy.
Class 7 cleanroom with capabilities for hermetic enclosure welding, laser processing, and fine-pitch component assembly.
Prototype development and assembly using high-speed robotics and IPC-qualified soldering techniques.
Full Design History File (DHF) documentation and Device Master Record (DMR) management.
Project management services utilizing agile and traditional methodologies.