AIMD & Peripherals

Developing Active Implantable Medical Devices (AIMDs) and their peripherals is one of the toughest challenges in medtech. Comate started building expertise in this field early on. Our expertise was built up from the mid-2000s, and we’ve repeatedly taken devices from concept to market. That experience means we know the pitfalls and how to avoid them. With a proven methodology and a multidisciplinary team, we turn prototypes into products that stand out for performance, safety and compliance.

AIMD development challenges

How do you turn a promising AIMD prototype into a safe, market-ready product? This transition is one of the most complex phases in development. Key challenges include:

Maximizing wireless power efficiency, ensuring stable device performance (for example, to ensure the pacemaker won’t occasionally skip a beat).
Building robust embedded software, with unit testing and cybersecurity integrated from the start.
Managing component lifecycles, selecting parts that guarantee long-term availability and minimize redesign needs.
Aligning multidisciplinary expertise, so electronics, mechanics and firmware evolve together.

Our approach

You have the idea; we help you bring it to life. With our structured, field-tested methodology, you can move from concept to market, backed by deep technical knowhow expertise and a clear process at every step.

At Comate, every discipline is under one roof: microelectronics, mechanics, usability & design, embedded firmware, ... Our multidisciplinary approach guarantees seamless progression from concept to finished product. Our ISO 13485-compliant QMS system, supported by in-house QARA experts, ensures regulatory compliance from day one. With dedicated experienced teams, we provide continuity and reliability throughout all your projects.

We have a lot of expertise in wireless power transfer (WPT), a crucial building block in almost every AIMD. Technical excellence always goes hand in hand with user-centered design. Plus, our pilot series production capabilities for clinical trials allow us to handle complex, small-scale batches that few others can manage.

Schedule your free call

Compliance & standards

We ensure full adherence to industry standards and regulations, including:

ISO 13485 – Quality Management Systems for medical devices
MDR (EU) 2017/745 – Medical device regulation
IVDR – In vitro medical device regulation
ISO 14971 – Risk management
ISO 14708 – Active implantable medical devices
IEC 60601 – Basic safety and essential performance of medical electrical equipment
IEC 62304 – life cycle processes for medical device software
IEC 62366 – Usability engineering
RED 2014/53/EU - Radio Equipment Directive

Acquisition Zenso x Comate

In 2022, Comate strengthened its medical electronics expertise by acquiring Zenso, a KU Leuven spin-off known for the development of Active Implantable Medical Devices.