Regulatory affairs
From design to commercialization
Regulatory requirements structure the entire lifecycle of medical devices, from design to market launch, and through post-market surveillance.
We support you in your regulatory procedures and in the preparation of your technical documentation, which are essential to obtain CE marking in Europe and FDA approvals in the United States.
To ensure high added-value support, we rely on the expertise of our sister company Cisteo Medical, a recognized specialist in regulatory affairs.
Our goal: to secure your market access while controlling timelines, costs, and risks.
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Your secure market access, from design to commercialization
Tame-Care supports you at every stage of the development of your medical devices by integrating regulatory requirements from the design phase through to market launch.
By leveraging the expertise of its sister company Cisteo MEDICAL, a specialist in regulatory affairs, Tame-Care ensures compliance with European (MDR) and US (FDA) requirements.
This integrated approach makes it possible to secure your technical files, anticipate regulatory changes, and facilitate interactions with authorities, while optimizing timelines, costs, and risk management.
Our support
Compliance with applicable requirements and standards
Our engineers work closely with the regulatory affairs teams at Cisteo MEDICAL, integrated directly into project development, to ensure from the earliest stages a design compliant with MDR, FDA requirements, and international standards such as ISO 13485.
This synergy between engineering and regulatory expertise is a key lever to secure and accelerate the development of your device.
Preparation of the technical file and CE / FDA compliance
The technical file, at the core of regulatory affairs, is developed and structured with the direct support of Cisteo MEDICAL experts to meet the requirements of notified bodies, European authorities, and the FDA.
The involvement of the teams in this key phase strengthens the robustness and credibility of your file during evaluations.
Management of regulatory changes
Change management, a critical issue in the lifecycle of a medical device, is handled by our teams in close collaboration with the regulatory experts of Cisteo MEDICAL, in order to document changes, assess their regulatory impact, and ensure compliance with CE and FDA requirements.
Our commitments
Comprehensive and up-to-date regulatory expertise
Tailored strategy and personalized support
Each project is unique, and we take the time to understand your specific needs and the characteristics of your medical devices. Our recommendations are tailored to your objectives and the markets you are targeting.
We develop customized strategies to streamline the registration process while minimizing risks.
We provide customized assistance in preparing technical documentation and implementing regulatory strategies, ensuring your medical devices meet the highest standards and are market-ready.
Assistance with Technical documentation
We support you in the creation and review of essential technical documents required for regulatory compliance.
We also ensure that these documents meet the applicable regulatory requirements.
Cisteo MEDICAL
FAQ
Can you help with the preparation of the regulatory technical file?
Yes. Tame-Care supports its clients in the complete preparation of the technical documentation required to place medical devices on the market, both in Europe and in the United States.
We help document the entire device lifecycle—design, development, and manufacturing—in compliance with MDR and FDA requirements. Our experts contribute to the drafting of reports, risk analyses, testing, and validations, ensuring that every element is traceable and justified for European and U.S. audits.
Thanks to this approach, the technical file is ready for CE marking and FDA inspections and approvals, enabling a fast, safe, and compliant market launch of medical devices.
What tests do you perform for certification?
At Tame-Care, we define and oversee all tests required for the certification of active medical devices, working in collaboration with specialized external laboratories.
We develop a comprehensive test strategy tailored to each device and aligned with regulatory requirements. Testing includes in particular:
- Functional tests to verify the correct operation of all features.
- Electromagnetic compatibility (EMC) and electrical safety tests to ensure compliance with standards.
- Environmental tests (humidity, heat, vibration) to validate robustness and durability.
- Software tests to ensure compatibility and security of embedded systems.
This approach validates the reliability, safety, and performance of the device while ensuring that test results are recognized for CE and FDA certifications.
Do you help your clients with ISO certification?
Support for change management in the context of medical devices is essential to ensure that all product or process modifications are properly documented and compliant with regulatory requirements.
Our teams assist you in managing these updates, whether related to the technical file, CE marking, or FDA approvals.
By providing complete and detailed documentation to be submitted to regulatory authorities, we help prevent any risk of non-compliance that could jeopardize the commercialization of the device.