Solutions

Design & Development

At OrthoSens, we turn medical device ideas into reality, blending design, engineering, and regulatory know-how. We start from simple concepts, refine them through iterative prototyping, and bring them to design-ready stage for manufacturing and testing. Our team focuses on users needs while minimizing risks. We closely collaborate with renowned manufacturing partners ensuring quality and compliance every step of the way.

Prototyping & Testing

At OrthoSens, we are following validated testing process for medical device development streamlined into crucial phases. Initially, we engage in early product characterization, using computer modeling and prototype testing. This is followed by Design Verification, ensuring the device meets its intended design specifications through a variety of tests like mechanical, electrical, and biocompatibility testing. The final phase, Design Validation, focuses on confirming the device fulfills original user needs, involving user testing, cadaver testing, and several other critical evaluations.

Regulatory Approval

At OrthoSens, we understand the crucial role of regulatory affairs in every stage of novel medical device's journey. From the initial concept to the final submission, our team crafts a tailored regulatory strategy to efficiently navigate the complexities of global compliance. We are focused on FDA & MDR approvals.