Medical Devices Standards Full Framework

A negative emissions technology that combines bioenergy production with carbon capture and storage. Biomass, which absorbs atmospheric CO2 as it grows, is combusted or processed to generate energy (electricity, heat, or biofuels). The resulting CO2 emissions from this process are then captured and permanently stored, typically in geological formations, resulting in a net removal of CO2 from the atmosphere.

Cradle-to-Cradle (C2C) is a design philosophy that models human industry on nature's processes. It views materials as "nutrients" circulating in closed-loop systems. The framework distinguishes between two cycles: the biological cycle, for biodegradable materials that can safely return to the soil, and the technical cycle, for materials that are continuously reused or upcycled in industrial processes without losing quality.

A technology designed to remove carbon dioxide directly from the ambient atmosphere, where its concentration is very low (~420 ppm). The two primary approaches use either liquid solvent systems, where air is passed through chemical solutions (e.g., potassium hydroxide), or solid sorbent systems, where air passes over filter-like surfaces that chemically bind with CO2. The captured CO2 is then released for storage or utilization.

Software as a Medical Device (SaMD) is defined as software intended for medical purposes that functions without being part of a hardware medical device. Governed by bodies like the International Medical Device Regulators Forum (IMDRF), SaMD is categorized based on the criticality of the information it provides and the healthcare situation, influencing its regulatory requirements.

Design for Six Sigma (DFSS) is a methodology applied to the design or redesign of products and processes, contrasting with DMAIC which improves existing ones. It aims to ensure the new design meets customer requirements and achieves Six Sigma quality levels from the outset. A common DFSS methodology is DMADV (Define, Measure, Analyze, Design, Verify).

A launch strategy where multiple small satellites are flown as secondary payloads on a rocket whose primary mission is to launch a larger, main satellite. This 'piggybacking' approach significantly reduces the cost for small satellite operators, as they only pay for a fraction of the total launch vehicle capacity, making space access more affordable and frequent for smaller players.

The Net Promoter Score (NPS) is a widely used market research metric that measures customer loyalty and their willingness to engage in word-of-mouth marketing. It is based on a single survey question: "How likely is it that you would recommend our company/product/service to a friend or colleague?" The score is calculated as the percentage of "Promoters" minus the percentage of "Detractors."

A group of numerous small satellites orbiting in a coordinated formation to achieve a common objective that a single, larger satellite cannot. These constellations provide global or near-global coverage with high revisit rates. Key applications include global broadband internet (Starlink), daily Earth observation (Planet Labs), and maritime/aviation tracking (Spire Global), enabled by the low cost of individual satellites.

The Unique Device Identification (UDI) system is a global standard for marking and identifying medical devices throughout their lifecycle. Mandated by regulators like the US FDA, a UDI consists of a device identifier (DI) for the specific model and a production identifier (PI) for batch, serial number, or expiration date. It enhances traceability, post-market surveillance, and patient safety.