Design tailored for manufacturing
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.
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
- For mobile application development, cloud data storage, and sharing, we collaborate with specialized partners who can support your needs.
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.
Contact
Offers tailored to the different stages of your project
High value-added services
Our Areas of Application
- Active medical devices Class IIA, IIB, III
- Active implantable medical devices
- Control and monitoring equipment
- In vitro diagnostic devices
- Exoskeletons
- Surgical robotics
- Imaging 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.
