Startup Lifecycle

Regulatory5

• General Safety and Performance Requirements(GSPRs)
• Instructions for Use(IFU)
• Ministry of Food and Drug Safety (Korea)(MFDS)
• Safer Technologies Program(STeP)
• Summary of Safety and Clinical Performance(SSCP)

Quality & Risk3

• Internal Audit
• Management Review
• Summative vs. Formative Evaluation

Cybersecurity1

• Software Safety Case

Clinical & Trials6

• Clinical Evaluation Report(CER)
• Data Safety Monitoring Board(DSMB)
• Early Feasibility Study(EFS)
• Feasibility Study
• Human Factors Engineering(HFE)
• Pivotal Trial

Standards5

• ASTM F2503
• IEC 60601-1
• IEC 60825
• IEC 82304-1
• ISO 10993-1

Software & AI1

• Software Safety Classification

Post-Market8

• Customer Notification Letter
• Field Safety Corrective Action(FSCA)
• Health Hazard Evaluation(HHE)
• Medical Device Vigilance
• Periodic Safety Update Report(PSUR)
• Post-Market Clinical Follow-up(PMCF)
• Post-Market Surveillance(PMS)
• PSUR (IVDR Specific)

Investment & Finance28

• Anti-Dilution Protection
• Bridge Round
• Burn Rate
• Burn Rate and Runway
• Capitalization Table(Cap Table)
• Convertible Note
• Dilution
• Down Round
• Due Diligence
• Employee Option Pool
• Exit Multiple
• Liquidation Preference
• Milestone Payment
• Milestone-Based Tranche
• Non-Dilutive Funding
• Post-Money Valuation
• Pre-Money Valuation
• Preferred Stock
• Pro-Rata Rights
• Runway
• SBIR / STTR Grants(SBIR/STTR)
• Simple Agreement for Future Equity(SAFE)
• Strategic Investor
• Term Sheet
• Tranched Financing
• Valuation Cap
• Venture Debt
• Vesting Schedule

Reimbursement2

• 340B Drug Pricing Program(340B)
• Health Technology Assessment(HTA)

Other ecosystems