Ricky Tjandra
Medical devices, from lab bench to market.
Design, quality systems, regulatory and IP, handled by one advisor from start to finish.
Why work with me
- I’ve done it end to end. I took a hardware, software and AI IVD system from the lab bench through animal and clinical studies to FDA 510(k) clearance, Health Canada licensing and SFDA registration. It’s on the market.
- I’m doing it now. VP of Medical Devices at FluidAI Medical, with 7 years in the medical device industry. I take on a small number of advisory engagements alongside that role.
- Science and regulation. PhD from the University of Waterloo, 20 peer-reviewed papers and 1,000+ citations. I design to ISO 13485 and 21 CFR 820.
- IP and funding. I grew the patent portfolio 6× to 18 families and helped secure $200K+ in non-dilutive funding.