This step focuses on identifying the requirements that influence design. The client’s needs and the desired functionalities of the medical device form the foundation of the conceptualization process. With your input, our teams consider the constraints related to the device’s usage: Is it implanted? Does it come into contact with the patient? What is its criticality level? In what environment will it operate?

Next, we collaborate with you to detail the technical specifications of the device. This includes the electronic, mechanical, electrical, and software parameters of the project, as well as functional and performance requirements. Each aspect is carefully examined to ensure the device is not only effective but also safe and reliable.
We leverage our extensive experience and knowledge of international standards and regulations, such as ISO standards, FDA guidelines, and CE marking directives, to ensure your product meets regulatory compliance.
Well-defined specifications allow design engineers to anticipate potential issues before they arise, saving both time and money.

The Tame-Care teams also analyze your project from a regulatory perspective. For any medical device project, defining its classification and that of its embedded software is essential, as this classification impacts the design and manufacturing methods of your product. It is therefore crucial to address this from the project definition phase.

This product regulation includes:

• Regulatory requirements for CE marking and/or FDA approval
• Compliance with “machine” directives
• Specific standards applicable to your product

With in-house expertise in regulatory affairs, our engineering team has a thorough understanding of applicable regulations and stays up-to-date with emerging standards for new medical technologies.