Design tailored for manufacturing
Active Implantable Medical Devices
Cutting-edge technologies at the heart of the human body
Active implantable medical devices (AIMDs) represent a concentration of innovation dedicated to healthcare. Designed to operate inside the human body, they must meet the highest standards of safety, reliability, and durability. For manufacturers, this involves complex technological decisions, advanced engineering, and strict compliance with regulatory frameworks.
Developing an AIMD—such as a neurostimulator, defibrillator, or smart intracorporeal sensor—means navigating a highly constrained environment. On one hand, innovation pressure is intense: manufacturers must integrate increasingly complex functions into ever-smaller volumes. On the other, regulatory bodies require rigorous validation, documentation, and traceability procedures at both the European (MDR) and international (FDA, ISO 13485) levels.
The challenges go far beyond design. Product industrialization, reproducibility, traceability, and post-market evolution are all critical phases. Meeting deadlines and managing risk are key success factors. In this context, working with an experienced partner capable of providing end-to-end support is a major strategic asset.
At Tame-Care, we understand these challenges. We support our clients from the earliest stages of their projects, helping to identify technical and regulatory constraints specific to each application. Whether it’s component miniaturization, energy optimization, or wireless communication management, our approach is focused on performance, safety, and clinical use.
Our support
With over 15 years of experience in developing AIMDs, Tame-Care is recognized for its ability to turn ideas into certified, reliable, and high-performance products. Our global, modular approach is built on multidisciplinary expertise—electronics, embedded software, mechanics, and regulatory affairs—and supported by ISO 13485-certified industrial infrastructure.
From the design phase, we contribute to system architecture, miniaturization, secure wireless communication, and regulatory compliance. We then manage the industrialization process to ensure reproducibility, quality, and compliance with medical standards (ISO 13485, MDR, FDA).
Device reliability is at the heart of our approach. We operate a dedicated component analysis lab and develop custom test benches to validate performance and robustness under real-world conditions.
Production takes place in our certified facilities under highly controlled conditions, with strict quality control and ISO 7 cleanroom environments.
Tame-Care is your committed partner throughout the entire device lifecycle.
The preferred partner for european AIMD manufacturers
Active Implantable Medical Devices demand absolute reliability, advanced miniaturization, and full compliance with the most stringent standards.
Our strength lies in full value chain control, a strong culture of innovation, and in-depth knowledge of both clinical and industrial expectations.
Our commitments for your implantable devices:
- Full mastery of regulatory requirements: ISO 13485, MDR, ISO 14708, FDA Class III
- Expertise in electronics, energy management, reliability, encapsulation, and biocompatibility
- Integration of advanced features: stimulation, telemetry, implantable batteries, transcutaneous energy transfer
- Production in ultra-controlled environments (ISO 7), with full traceability
- Maximum confidentiality and long-term support
We bring our exacting standards to your most critical medical devices.
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