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When engaging with an Independent Design House (IDH) for medical device development, companies must prepare a set of essential documents, materials, and resources to ensure a smooth collaboration.

The success of a device depends on how well it integrates into existing clinical workflows and meets the practical needs of healthcare providers and patients.

Our approach is designed to mitigate risk, enhance collaboration, and accelerate time-to-market while maintaining strict compliance with medical regulations like ISO 13485, IEC 60601, and FDA guidelines.

Industry leaders in medical devices—whether large OEMs or established MedTech firms—expect Independent Design Houses (IDHs) to meet high standards in engineering expertise, regulatory compliance, risk management, and operational reliability. These companies are not just looking for a vendor but a long-term, strategic partner who can help bring innovative, market-ready devices to life efficiently and compliantly.

A Design for Cost (DfC) approach ensures that a product meets performance, safety, and compliance standards while remaining cost-effective from development to mass production.

Automated production is transforming medical device manufacturing by improving efficiency, consistency, and scalability while reducing costs and human errors. However, automation only works effectively when products are designed with DfM (Design for Manufacturability) principles in mind.

SaMD is transforming healthcare with AI & cloud, enabling precise diagnosis, real-time monitoring, and AI-driven clinical decision-making.

Explore 7 biosensors in wearables, including ECG, EEG, and PPG, with ITR VN, a reliable partner in MedTech solutions, ensuring advanced health monitoring.