Systems engineering aims to systematically develop systems – in this context, medical devices – in the planned time and quality.
Content
This page helps manufacturers of medical devices and their service providers to gain an overview of systems engineering and to find further articles on the subject:
According to the ISO/IEC 15940 definition, systems engineering is …
… interdisciplinary approach governing the total technical and managerial effort required to transform a set of customer needs, expectations, and constraints into a solution and to support that solution throughout its life.
Wikipedia has also adopted this definition of systems engineering.
ISO/IEC/IEEE 21841 speaks of a process of planning, analysis, organization, development, and integration.
The V-model is a well-known model for the development process. It is suitable as a documentation model for the (agile) development of medical devices.
As part of this process, manufacturers carry out various activities for which further articles provide guidance. They can set up their development team for these activities and/or have activities carried out by third parties.
In the latter case, these articles are relevant:
Usability engineering and, thus, the verification and validation of usability are also part of systems engineering. You can find further information on systems engineering by clicking on this link.
Risk management is a special feature of systems engineering for medical devices. You will find an overview of articles on risk management by clicking on this link.
The regulatory requirements are based on EU regulations and directives:
The central standard is IEC 60601-1, which was extended by a 2nd amendment in 2019. IEC 61010-1 is relevant for IVDs.
The concepts of the standard(s) include:
In addition to the basic standard, the particular standards are also relevant:
Many manufacturers rely on the CB Reports to provide evidence.
There are special standards for devices that are intended to come into contact with the human body:
ISO 17664 is relevant for the reprocessing of medical devices.
Please also refer to our article on substance-based medical devices.
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Regulations such as the MDR require proof of the biocompatibility of all materials that come, directly or indirectly, into contact with patients or users. A test-based biocompatibility assessment provides reference data that provides a very good basis in the event of unexpected problems and that helps to quickly and directly identify unknown causes. However, there…
DetailsWhat is the difference between verification and validation, and how are these terms defined? Even standards and regulations use the terms incorrectly or misleadingly. This article 1. Verification a) Definition This definition does not explain what type of “requirements” need to be confirmed by verification. Limiting these requirements to product or component requirements is recommended to avoid…
DetailsThe ISO 10993-17 standard is part of the ISO 10993 series of standards on biocompatibility. ISO 10993-17 describes the procedures for Toxicological Risk Assessment. In the fall of 2023, a comprehensive standard revision was published after over 20 years. Medical device manufacturers should know, This article will help. 1. Context of ISO 10993-17 1.1 The…
DetailsDirective 2014/53/EU (Radio Equipment Directive (RED)) applies to devices that use Wi-Fi or RFID, for example. Medical devices that send a radio signal because they connect to the internet or are operated remotely also need to demonstrate conformity with the RED before being marketed. In this article, learn more about 1. Applicability of the RED…
DetailsPhantoms in medical technology help to develop, validate, “approve” and monitor medical devices in the markets faster and more effectively. This article describes which organizations particularly benefit from the use of these phantoms and what requirements they must meet. 1. Examples of phantoms in medical technology Anthropomorphic phantoms are replicas of bodies that behave like…
DetailsUnderstandably, laws and standards also require IT security for legacy devices. However, the way in which these requirements are formulated often leads to confusion. For example, legislators and standard committees have been unable to agree on common definitions. One definition refers to the IT security of legacy devices, another to the IT security of old…
DetailsMedical devices are increasingly based on closed-loop systems. “Closed-loop systems” are also mentioned in the Medical Device Regulation (MDR). In this article you will learn what closed-loop systems are, where they are used in medicine, and what regulatory requirements they need to meet. The article also reveals how you can save several hundred euros buying the…
DetailsFor manufacturers, the answer to whether and when clinical studies are necessary when using artificial intelligence in medical devices is relevant. After all, the duration and cost of bringing these devices to market depend on this. The good news in advance: there are cases where manufacturers can avoid clinical studies for devices with AI. This…
DetailsWith PFAS, the EU plans to ban an entire class of chemicals. In doing so, it is not only threatening the supply of medical devices but also the competitiveness of EU manufacturers. After all, the assumption that manufacturers inside and outside the EU are treated equally is just one of the EU’s five misconceptions in…
DetailsASCA stands for Accreditation Scheme for Conformity Assessment. The procedure is intended to accelerate conformity assessments and, thus, approval procedures. However, it is not applicable to all devices or all markets. This article explains who benefits from ASCA and how the procedure works. 1. ASCA – The basics a) Who is affected by ASCA? ASCA…
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