Medical Devices
Developing medical devices goes far beyond the technical challenge. It’s about building safe, reliable and compliant solutions that meet strict regulatory requirements.
At Comate, we focus on the Design & Engineering and low-volume production phases of medical device development. With our ISO 13485 certification and proven methodology, we deliver robust products, plus the documentation needed.
The best starting point for working with us is when you already have clinical data on the problem and a first potential market in mind. With pilot production capacity, we provide the samples you need for verification and validation. That’s where our expertise makes the difference: translating insights into a safe, manufacturable and certifiable device.
The challenge
Developing medical devices comes with its own specific set of challenges:
- Building the right documentation, not as an afterthought, bus as the foundation for compliance.
- Aligning prototypes with readiness for clinical trials, ensuring that every iteration meets the required approvals or documentation.
- Navigating regulatory pathways, by embedding design control and risk management early in development.
- Integrating usability from the start, so user-centered design beats the manuals.
Our approach
We take ownership of the design, engineering and production documentation so you don’t have to. Our engineers and designers are trained in lean documentation practices, supported by templates and workflows. With our Design History Generator (DHG), we have a portal that gives you 24/7 access to the latest revisions complete set of documentation of your device.
For usability engineering, we follow IEC 62366 rigorously, embedding user needs directly into the design process. With our unique expertise in wireless power transfer (WPT), we support not just implantable but also wearable and external devices.
Proven track record
We have helped medical innovators bring safe, compliant devices to the market:
Compliance & standards
Our development processes are aligned with the necessary medical device standards and regulations, including:
- ISO 13485 – Quality Management Systems for medical devices
- MDR – Medical Device Regulation for production and distribution
- IEC 60601 – Basic safety and essential performance of medical electrical equipment
- IEC 62304 – Medical device software lifecycle processes
- IEC 62366 – Usability engineering
- ISO 14971 – Risk management
We combine design controls (ISO 13485) with risk management (ISO 14971) and product-level standards to ensure your device meets every requirement of the Medical Device Regulation (EU) 2017/745 or the In vitro Medical Device regulation (EU) 2017/746
Let’s solve your medtech challenge
Medical devices come with complex technical and regulatory hurdles. Let’s explore how we can help you bring your device to market.