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:
- Articles on processes and activities in the device life-cycle
- Articles on the IEC 60601-1 family and physical safety
- Articles on biocompatibility, sterility, and reprocessing
Definition of systems engineering
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.
1. Articles on processes and activities
a) Processes
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:
- Outsourcing in medical technology
- Engineering service providers: successfully outsourcing development?
b) Formulate intended purpose and requirements
c) Designing systems
- Creating a system architecture for medical devices, ideally not a layered architecture
- Creating safety concepts to achieve functional safety
- Using modeling languages such as the Unified Modeling Language (UML)
- Creating designs using Computer-based Modeling & Simulation (CM&S)
- Performing threat modeling for systems that contain software for IT security
- Carrying out a design validation
- Developing software in compliance with the law
d) Verifying and validating systems
e) Further phases in the life-cycle
Notes and further information
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.
2. Articles on the IEC 60601-1 family and physical safety
a) Regulatory requirements
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:
- Basic safety, essential performance
- Functional safety
- MOPP, MOOP, MOP, and the IEC 60601 arithmetic
In addition to the basic standard, the particular standards are also relevant:
Many manufacturers rely on the CB Reports to provide evidence.
b) Implementation of requirements for specific systems and situations
- Systems, devices
- Components, parts
3. Articles on biocompatibility, sterility, and reprocessing
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.
Do you need support?
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Would you like support in developing your medical devices in compliance with the law, testing, and authorizing their safety? The Johner Institute team will be happy to help! Contact us!
ASCA 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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The system architecture describes the components of a (medical) device and how these components interact with each other via interfaces. For standalone software, the system architecture and software architecture coincide. 1. Documentation of the system architecture a) Notation language The documentation should reveal the individual components and their interaction. It has been proven that using…
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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…
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The correct and precise formulation of the intended purpose of medical devices and in vitro diagnostic medical devices (IVD) is crucial for their successful development and approval. However, even the definitions of terms and the distinction between intended purpose and intended use make it difficult to achieve clarity and precision. This article reveals how to…
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What 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…
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The 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…
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Directive 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…
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Phantoms 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…
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Understandably, 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…
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Medical 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…
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