--- title: "Ecosystems - MedTech Terms" description: "Cross-cutting MedTech ecosystems: AI/ML, connected devices, software lifecycle, quality system, hospital buyer, startup lifecycle, and more." lang: en json-ld: --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About Browse # Ecosystems Cross-cutting buckets that group terms by the world they live in - independent of the rigid taxonomy. A term can belong to several at once. - [ 114 terms ## Regulated Pathways Getting a device cleared, approved, or certified. Submission types, review pathways, and the regulators who run them - from 510(k) and PMA to CE marking under MDR and global routes through PMDA, NMPA, and MHRA. Explore ](/ecosystems/regulated-pathways) - [ 40 terms ## AI / ML in Devices Models, governance, and oversight for AI-enabled devices. Everything specific to AI/ML-enabled medical devices - predetermined change control plans, model cards, the EU AI Act, ISO/IEC 23894, and the data-and-bias practices that regulators now expect. Explore ](/ecosystems/ai-ml) - [ 64 terms ## Connected & Cyber-Physical Devices Security, networks, and SBOMs for devices that talk to the world. The full cybersecurity stack for connected medical devices: SBOMs, threat modeling, secure-by-design, vulnerability disclosure, and the FDA, IMDRF, and HSCC guidance that defines today's expectations. Explore ](/ecosystems/connected-devices) - [ 47 terms ## Software Lifecycle SaMD, SiMD, and the standards that govern device software. How software-as-a-medical-device and embedded device software get designed, verified, validated, and maintained - IEC 62304, IEC 82304, usability standards, and the IMDRF SaMD risk framework. Explore ](/ecosystems/software-lifecycle) - [ 91 terms ## Quality System QMS, risk, and design controls under ISO 13485 and 21 CFR 820. The quality management backbone of every device manufacturer - design controls, CAPA, risk management to ISO 14971, and the move from QSR to QMSR in the United States. Explore ](/ecosystems/quality-system) - [ 81 terms ## Clinical Evidence Trials, investigations, and human-factors studies. How devices generate the clinical evidence regulators and payers demand - IDE studies, pivotal trials, real-world evidence, ISO 14155, and human-factors validation. Explore ](/ecosystems/clinical-evidence) - [ 33 terms ## Post-Market & Safety Vigilance, recalls, MDRs, and lifecycle surveillance. What happens after launch: adverse event reporting (MDR/MIR), recalls, FDA warning letters, periodic safety reports, and the post-market surveillance plans MDR requires. Explore ](/ecosystems/post-market-safety) - [ 111 terms ## Global Markets Region-specific routes: US, EU, UK, Japan, China, and beyond. How the same device is registered across the world's major markets - the agencies, the labels, and the timelines that define a global launch sequence. Explore ](/ecosystems/global-markets) - [ 60 terms ## Hospital Buyer & Reimbursement How devices get bought, coded, and paid for. The commercial reality of selling into health systems: GPOs, IDNs, value analysis committees, CPT/HCPCS coding, ICD-10, NCD/LCD coverage, and specialty payment pathways like NTAP and TCET. Explore ](/ecosystems/hospital-buyer) - [ 80 terms ## Startup Lifecycle Financing a MedTech company from seed to exit. Term sheets, valuation, liquidation preferences, tranched financing, and the milestones that move a MedTech startup from preclinical to commercial. Explore ](/ecosystems/startup-lifecycle) - [ 52 terms ## Strategic Landscape Market segments and the industry bodies that surround them. Therapeutic and technology segments, the trade associations and standards organizations that shape them, and the accelerator and incubator programs that build the next wave of companies. Explore ](/ecosystems/strategic-landscape) - [ 30 terms ## Manufacturing & Supply Design transfer, production, and the supply chain. Process validation, design transfer, contract manufacturers, sterilization, UDI, and the supply-chain controls that keep finished devices flowing. Explore ](/ecosystems/manufacturing-supply) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)