- Idea Solicitation ProgramTool created that outlines and explains various programs & techniques for generating new product ideas internally and externally, and for ultimately keeping the new product development pipeline full. Read More
- IEC 61160Standard covering design reviews. Read More
- Incremental Product ChangeUsually offers a modest enhancement in features or functionality. It commonly extends a product line or fills a minor gap in the existing product line. Read More
- Independent ReviewerIndividual(s) included in a design review, who is not directly responsible for the design being reviewed, and has sufficient knowledge or experience to evaluate the design objectively. Read More
- Indications for UseDescribes the disease or condition under which the medical device will be used and under what conditions. Read More
- Inductive ReasoningInductive reasoning makes broad generalizations from specific observations (bottom-up). The investigator collects observations, finds patterns in the data, makes tentative hypotheses and finally presents a theory or rationale that explains the patterns. Theories generated through inductive(...) Read More
- InnovationAn innovation creates value for the customer in a new and unique way. As Peter Drucker said, a product that is different, but does not create new value for the customer, is merely a novelty. A novelty may temporarily capture a customer’s interest because it is different, but it will quickly be(...) Read More
- Instructions for UsePart of medical device labeling which provides the directions on how to use the product and may be physical or electronic. Examples include: label, package insert, and user manual. Read More
- Intended UseGeneral information on what the medical device does, who the product is intended for, and how it would be used. Read More
- ISO 13485Standard which covers the Quality Management System for Medical Devices. It is based on ISO 9001, but contains elements specific to Medical Devices. Read More
- ISO 14971Standard covering user and patient risk management for medical devices. Read More