Knowledge Base - BE Health Ventures | VC & Accelerator

Knowledge Base

FDA Review Lens | How to Build Compliant Data Governance for Medical AI Data Rights, De-identification, and Audit Trails: 7 Common Rejection Traps and Ready-to-Use Fix Templates

BE Health Ventures | VP of Investment & Clinical

2026年5月14日

FDA Review Perspective | How Can AI SaMD Teams Practically Implement IEC 62304?

BE Health Ventures | VP of Investment & Clinical

2026年5月14日

The FDA Review Perspective | Should AI Medical Startups Choose 510(k) or De Novo? A Classification Decision Tree, the Cost of Choosing the Wrong Predicate, and 3 Mitigation Strategies

By Hsin-Wei Shen, VP of Investment & Clinical Strategy, BE

2026年5月11日

FDA Reviewer Perspective: How to Write the Intended Use for AI Medical Products? 7 Common Rejection Pitfalls and Correction Templates

You might think that an AI medical product will

2026年3月25日

Key Milestones in Medical Device Product Development

Shen Hsin-Wei, Vice President of Medical Affairs, BizLink Biotech Venture

2025年9月30日

MVP (Minimum Viable Product) in Medical Product Development

Shen Hsin-Wei, Vice President of Medical Affairs, BizLink Biotech Venture

2025年9月30日

Evaluating Market Viability for Medical Innovation

Shen Hsin-Wei, Vice President of Medical Affairs, BizLink Biotech Venture

2025年9月30日

Finding Startup Inspiration from Unmet Clinical Needs

Shen Hsin-Wei, Vice President of Medical Affairs, BizLink Biotech Venture

2025年9月30日