Lecture

Medical Devices Regulation

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In course

BIO-455: Introduction to law and ethics

The aim of this course is to introduce students to the basic legal and ethical concepts relevant to research in the life sciences and its translational application, and to provide them with the essential tools to identify legal and ethical issues in their ...

Description

This lecture covers the European and Swiss regulations on medical devices, including the authorization regime before and after market placement, anti-corruption compliance, and key concepts. It discusses the new legislative framework, the role of the manufacturer, general safety and performance requirements, risk-based controls, post-market surveillance, and the importance of ethical business practices in the industry.

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Official source

Ontological neighbourhood

Systems science and engineering

Systems thinking: Systems engineering

Related concepts (32)

Requirements analysis

In systems engineering and software engineering, requirements analysis focuses on the tasks that determine the needs or conditions to meet the new or altered product or project, taking account of the possibly conflicting requirements of the various stakeholders, analyzing, documenting, validating and managing software or system requirements. Requirements analysis is critical to the success or failure of a systems or software project.cite book |editor1= Alain Abran |editor2=James W.

Business requirements

Business requirements, also known as stakeholder requirements specifications (StRS), describe the characteristics of a proposed system from the viewpoint of the system's end user like a CONOPS. Products, systems, software, and processes are ways of how to deliver, satisfy, or meet business requirements. Consequently, business requirements are often discussed in the context of developing or procuring software or other systems. Three main reasons for such discussions: A common practice is to refer to objectives, or expected benefits, as 'business requirements.

Non-functional requirement

In systems engineering and requirements engineering, a non-functional requirement (NFR) is a requirement that specifies criteria that can be used to judge the operation of a system, rather than specific behaviours. They are contrasted with functional requirements that define specific behavior or functions. The plan for implementing functional requirements is detailed in the system design. The plan for implementing non-functional requirements is detailed in the system architecture, because they are usually architecturally significant requirements.

Proprietary software

Proprietary software is software that, according to the free and open-source software community, grants its creator, publisher, or other rightsholder or rightsholder partner a legal monopoly by modern copyright and intellectual property law to exclude the recipient from freely sharing the software or modifying it, and—in some cases, as is the case with some patent-encumbered and EULA-bound software—from making use of the software on their own, thereby restricting their freedoms.

Requirement

In product development and process optimization, a requirement is a singular documented physical or functional need that a particular design, product or process aims to satisfy. It is commonly used in a formal sense in engineering design, including for example in systems engineering, software engineering, or enterprise engineering. It is a broad concept that could speak to any necessary (or sometimes desired) function, attribute, capability, characteristic, or quality of a system for it to have value and utility to a customer, organization, internal user, or other stakeholder.

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