At Tame-Care, we are proud to be a trusted partner for medical device manufacturers seeking access to the U.S. market.
Our expertise covers all FDA requirements, from design to production, with full mastery of quality systems and regulatory obligations.
Clients choose us for our ability to secure processes, reduce risks, and accelerate time-to-market.
By choosing Tame-Care, you benefit from an FDA-recognized contract manufacturer capable of:
Designing compliant and safe devices,
Delivering reliable, high-quality series production,
Supporting your regulatory processes to accelerate market access.
We combine technical rigor, regulatory expertise, and industrial excellence to ensure the success of your projects in the U.S. market.
We incorporate the main FDA regulations into all our processes:
21 CFR Part 820 – Quality System Regulation (QSR): a fully compliant quality system that meets FDA audit requirements.
21 CFR Part 11: secure management of electronic records and electronic signatures.
Full traceability of components, batches, and devices to ensure complete tracking.
This rigorous approach ensures that every product manufactured at Tame-Care is ready for inspection and fully compliant with U.S. standards.
Tame-Care applies the Design Control requirements expected by the FDA:
Full management of product requirements and traceability.
Risk analysis according to ISO 14971.
Verification and validation of devices, software, and embedded systems.
Documentation adapted to 510(k), PMA, or Exemption submissions depending on the device type.
Our methodology ensures that every project meets FDA expectations from the design phase onward.
We ensure production in compliance with U.S. standards:
Process validation (IQ / OQ / PQ) and equipment qualification.
Strict quality control on every batch and critical component.
Qualification of suppliers and subcontractors to meet QSR requirements.
Complete traceability and document management aligned with the FDA quality system.
This level of control allows our clients to benefit from robust, reproducible production that is ready for the U.S. market.
