Global regulatory affairs consultation services, including CE, FDA, Taiwan FDA, and China FDA. HKBio can guide you through the intricate processes and get your products onto the market faster.
HKBio aims to accelerate the worldwide distribution of high impact medical solutions through our global partners network and deep knowledge in the local healthcare systems.
HKBio has decades of medical device R&D and production expertise. We can improve your medical device product designs by optimizing materials and electro-mechanical structures.
Unlike most contract development firms, HKBio is interested in engaging with medtech innovations early. We can start at the new product introduction (NPI) phase by taking your idea from an initial working prototype.
HKBio is a full service contract manufacturing partner which provides end-to-end fabrication from design to manufacturing of final products, quickly and cost-effectively.
HKBio is ISO13485 compliant and has assembly capabilities, even for smaller volumes.
We also adopts the lean manufacturing and continuous improvement schemes to ensure our processes are consistently improving.