Consulting
Are you an early‑stage medical device start‑up, particularly in the in vitro diagnostics (IVD) field? I can help you navigate the entire product lifecycle. With a background in leading cross‑functional teams through research, development, validation, IP management, and launch, I offer end‑to‑end consulting services in:
- Product development: translating cutting‑edge research into manufacturable, scalable products.
- Quality management systems: implementing and optimizing ISO 13485 and 21 CFR 820 compliant design controls.
- Regulatory strategy: developing submission dossiers and liaising with regulators for FDA 510(k) clearance, Health Canada approval and SFDA certification.
- Intellectual property strategy: mapping patent landscapes, performing freedom‑to‑operate analyses and safeguarding your innovations to build a strong IP portfolio and maximize commercial value.
Proven track record
I spearheaded the development of a novel, complex IVD system that combines hardware, software and AI components. Starting from a lab‑bench concept, this technology advanced through animal and clinical trials and ultimately achieved regulatory clearance in the United States (FDA 510(k)), Canada (Health Canada) and the Kingdom of Saudi Arabia (SFDA). The product is now commercially available and delivering meaningful improvements in patient care.
If you’re looking for a partner who understands the science, regulatory landscape and intellectual property strategy, please reach out via LinkedIn to explore how we can accelerate your path to market.