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Medical device companies expanding globally face a critical strategic decision: which regulatory pathway offers the fastest, most...

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-

A medical device Quality Management System (QMS)  proves you can consistently design, make, and support safe, effective devices. It's...

A Predetermined Change Control Plan (PCCP) is FDA documentation that lets you pre-define specific AI/ML software changes—and the methods...

FDA consensus standards are voluntary international standards that FDA recognizes for medical device submissions. Companies can submit a...

Medical device development runs from concept through design controls, verification and validation, clinical investigations when needed,...