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What Is IMDRF? 2025 AI/ML & SaMD Guide (N88 GMLP + N81 Risk)
IMDRF is the global forum harmonizing medical device regulations across major markets (FDA, MHRA, Health Canada, EU). On Jan, 2025, IMDRF...
Aug 11, 20256 min read
EU MDR vs FDA: 2025 US-EU Medical Device Regulatory Comparison Guide
Medical device companies expanding globally face a critical strategic decision: which regulatory pathway offers the fastest, most...
Aug 10, 202511 min read
How to Fund a Medical Device Startup: 2025 Guide (Grants, Angels, VC & Non-Dilutive Options)
Medical device startups have 8 primary funding sources: government grants ($305K-$3M, non-dilutive), angel investors ($50K-$2M, 10-25% equity), venture capital ($1M-$100M+, 15-30% equity per round), crowdfunding ($50K-$1M, variable terms), accelerators ($25K-$250K + mentorship), corporate partnerships, revenue-based financing, and bootstrapping. The smart play is sequencing: validate with grants, bridge with angels, then scale with venture—layering in partnerships or revenue-
Aug 8, 202510 min read
Medical Device QMS (2025): ISO 13485 & FDA QMSR 2026 Guide
A medical device Quality Management System (QMS) proves you can consistently design, make, and support safe, effective devices. It's...
Aug 7, 20255 min read
Predetermined Change Control Plan (PCCP) for AI/ML-Enabled Devices: 2025 FDA Guide
A Predetermined Change Control Plan (PCCP) is FDA documentation that lets you pre-define specific AI/ML software changes—and the methods...
Aug 6, 202510 min read
FDA Consensus Standards for Medical Devices: US Declaration of Conformity Guide 2025
FDA consensus standards are voluntary international standards that FDA recognizes for medical device submissions. Companies can submit a...
Aug 6, 20258 min read
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