Electronic, mechanical and software design
Recognized expertise
The design of medical devices involves significant challenges, from patient safety to the sector’s stringent regulations. At Tame-Care, we are here to support you at every stage of your project, providing you with our technical expertise and experience in the healthcare field.
Our team offers comprehensive and tailored services for the design of medical devices, encompassing electronic, mechanical, and software aspects with the goal of transforming your idea into a high-performing, reliable, and compliant medical device.
Achieving the expected performance level at a target cost and with a design optimized for production are the key challenges in developing a new product.
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Our support
Electronic design
Our team of electronic engineers designs custom electronic systems tailored to the specific needs of your medical device. We handle component selection, circuit simulation, prototyping, and validation testing to ensure the performance and reliability of your product.
With a specialized electronic component lab, we can also assist you in selecting and qualifying electronic components.
Mechanical design
Our mechanical engineering experts develop the structures and mechanical components of your device, emphasizing ergonomics, durability, and compliance with medical standards. We use advanced CAD software to create virtual prototypes and perform stress and performance analyses.
Software development
Tame-Care’s software team specializes in embedded software development. We create intuitive and secure user interfaces, ensuring seamless integration with electronic and mechanical systems.
Our expertise includes:
- Development of medical software (IEC 62304)
- Software architecture design
- V&V and compliance testing
- UI/UX for medical applications
Regarding mobile application development, cloud storage, and data sharing, we work with specialized partners who are equipped to support you.
Prototyping
To ensure the best results, we produce prototypes of the design during the final phase using innovative techniques. This allows us to conduct all necessary tests and validate the product according to applicable specifications and standards.
Regulatory support
Tame-Care supports you in preparing technical documentation and managing regulatory processes to ensure that your medical device complies with all legal and normative requirements.
Our fields of application
Therapeutic devices
Diagnostic devices
Implantable devices
Surgical devices
The advantages of Tame-Care
ISO 13485 certification
We are ISO 13485 certified in the design, prototyping, and engineering of medical devices. Additionally, we have an in-house team of regulatory experts. With this certification and expertise, we ensure that the entire design and development process for your medical device is carried out in compliance with all relevant regulatory requirements and standards.
An experienced and Multidisciplinary design office
With our experienced, multidisciplinary design office of 50 professionals, we provide the essential engineering and expertise needed for medical device design projects.
We leverage our proven product design processes, as well as our know-how and skills, to support your projects in line with your specifications. Backed by our experience and innovative capabilities, our design office offers advanced technological solutions in areas such as energy, connectivity, encapsulation, and cybersecurity.
A design office in constant collaboration with production
We work closely with Manufacturing, ensuring a deep understanding of the strict constraints inherent to the production of critical medical devices.
Additionally, our team conducts a thorough analysis of the bill of materials in collaboration with our procurement team to ensure optimized sourcing throughout your product’s lifecycle.
Design for excellence
80% of a product’s cost is typically determined during the design phase. That’s why we start early with DfX, encompassing all design and manufacturing processes. Your product is continuously optimized for performance and quality, improving time-to-market and ensuring your complete satisfaction.
DfX ensures:
- Specified materials and components are always available/replaceable
- Manufacturing waste is minimized
- Production errors are reduced
- Products consistently meet required standards
- Products can be tested easily and cost-effectively
Regulatory expertise
Comprehensive knowledge of current medical device regulations is essential to guide the design and validation of your product. At Tame-Care, we have dedicated regulatory affairs resources that enable us to study each standard, design with these constraints in mind, and assist you in creating your regulatory dossier.
FAQ
Can you develop a product from A to Z?
Yes, Tame-Care can develop an active medical device from A to Z. Our teams cover the entire design and development process, with full expertise in electronics, mechanics, and embedded software.
We support our clients at every stage:
- Consulting and concept definition: needs analysis and selection of appropriate technologies.
- Design: electronic, mechanical, and embedded software development, integrating standards and regulatory requirements (MDR, IEC 62304, etc.).
- Prototyping and testing: creation of proof-of-concept and functional prototypes, with technical validation and environmental and EMC testing.
This integrated approach allows us to transform your ideas into innovative, reliable, and compliant medical devices.
What types of medical devices do you handle?
At Tame-Care, we exclusively handle active medical devices, meaning devices that integrate mechanics, electronics, and embedded software.
We work across the following regulatory classes:
- Class IIa
- Class IIb
- Class III
- AIMD – Active Implantable Medical Devices
- IVD – In Vitro Diagnostic Medical Devices when they include electronic or software functions
What is your role in firmware design?
At Tame-Care, we manage all aspects of firmware for active medical devices, from initial design to final validation.
We design and develop custom embedded software integrating critical features such as sensor management, motors, wireless communication, and user interfaces.
Safety and reliability are central to our approach: developments comply with IEC 62304, with testing and validation protocols ensuring performance, robustness, and energy optimization while supporting miniaturization.
We work closely with hardware and mechanical teams to ensure optimal firmware integration and support clients through industrialization and maintenance, ensuring long-term device sustainability.
What types of communication technologies do you support?
At Tame-Care, we master all communication technologies required for active, implantable, or connected medical devices.
We work with:
- Wired communication: for reliable exchanges in critical or complex systems.
- Wireless communication: Bluetooth Low Energy (BLE), Wi-Fi, NFC, LoRa, for secure transmission of patient or device monitoring data.
- Specialized medical communication: protocols compliant with medical standards, compatibility with hospital systems, IoT, and remote monitoring solutions.
We support clients in selecting the right technology, developing hardware and software architecture, and integrating firmware and control systems to ensure reliability, safety, and performance.
How do you ensure patient safety?
At Tame-Care, patient safety is integrated from the earliest design and development phases.
We apply rigorous risk management in accordance with ISO 14971 to:
- systematically identify and assess all risks related to the device,
- implement risk control measures from the design stage,
- integrate critical safety mechanisms to prevent failures and protect users.
This approach enables the design of reliable, safe, and compliant medical devices from the very beginning of development.
Are you able to provide rapid prototyping?
Yes, Tame-Care offers rapid prototyping to accelerate the development of active medical devices.
Through our sister company Team31, we quickly design functional prototypes.
This approach allows us to produce realistic, testable models in a very short time while enabling rapid iterations to validate and optimize the design before industrialization.
Can you take over a project already started by another provider?
Yes, Tame-Care can take over a partially developed device, whether it is an existing prototype or an incomplete design.
We then carry out:
- a technical and regulatory audit of the project,
- a compliance analysis against MDR/FDA standards,
- a study of risks, obsolescence, or critical points,
- the definition of a recovery or securing plan.
This approach helps strengthen the reliability of the device before continuing development or industrialization.
Can you miniaturize an existing medical device?
Yes, we have advanced expertise in miniaturization:
- electronic optimization (high-density boards, miniature components, low-power design),
- compact mechanical design and 3D modeling,
- thermal optimization,
- integration of batteries, sensors, antennas, or miniature motors,
- embedded software optimized for low power consumption.
Miniaturization is especially critical for implants, wearable devices, or embedded systems and is a core part of Tame-Care’s expertise.
Do you conduct clinical trials?
Tame-Care does not directly conduct clinical trials, but we:
- prepare devices, prototypes, and required documentation,
- collaborate with clinical partners,
- support clients in pre-clinical regulatory processes,
- ensure technical compliance for the clinical phase.
This ensures a smooth transition toward clinical trials.