AM Biomed Works
Make a customized medical device
During the COVID-19 pandemic, Hsintai Integration Biomed established a Taiwan FDA-licensed medical device production facility. The facility, which has undergone rigorous FDA audit, is equipped with state-of-the-art SLA and FDM additive manufacturing machines and biocompatible materials to ensure high-quality production.
Starting in May 2022, we are offering our services for biomedical applications, including the prototyping of medical implants and the development of surgical tools to enhance surgical procedures. Our attention to detail and ability to understand the specific needs of different specialties sets us apart. We welcome any inquiries and look forward to serving your needs.
From doctor need, we provide it better
At the heart of our values lies our commitment to solving the problems faced by doctors during complex or challenging procedures. Our goal is to provide vertically integrated medical device design and fast, small-scale production at a medical-grade level. All a doctor needs to do is present their patented ideas or drawings and we will bring them to life. Our mission is to support healthcare professionals by delivering the tools they need to achieve successful outcomes.
Stay focused on your product
- Unmet clinical or engineered Need
- Pilot production evaluation
- Product life cycle control
- Iteration with AM manufacturing
- Risk management control
Taiwan FDA medical device works
- 2022 Q3, Quality management system (QMS) issued
- 2023, Q1 TFDA license (Class I, needle guide) for customized medical device application
- 2023, Q2 TFDA license (Class I, Cranioplasty materials forming module)