Category "Systems Engineering for Medical Devices"
Systems Engineering for Medical Devices
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.
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?
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:
Do you still have questions about your medical device’s development, inspection, and approval? Then, please take advantage of our free micro-consulting service.
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!
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.
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…
For 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…
With 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…
The term “medical device PC” is not clearly defined. However, most people understand a medical device PC to be Depending on the constellation, manufacturers must fulfill different regulatory requirements. These are presented in this article.
The V-model is a development process model that was originally used for government projects (e.g., armaments). To this day, it is still anchored in many people’s minds and in standards for projects in regulated environments (e.g., medical technology, banks). This leads to disputes in teams that prefer agile development processes. This article helps to resolve…
Medical device manufacturers are obliged to both describe the development process and create a development plan. Because both documents specify how medical devices will be developed, there is uncertainty as to which information belongs in which document. This article resolves this and also examines the software. It looks at the software development plan and the…
Laws and standards formulate requirements on how medical device manufacturers must define and document the development process. Notified bodies check these requirements during audits. This article on the development process provides tips on how to design the process and how to align it with other processes, such as the risk management process.
Medical devices must comply with the legal requirements for functional safety. Unfortunately, the relevant standards and laws for medical devices do not define or use the term “functional safety.” This article provides clarity.
In May 2016, the German version of IEC 60601-1-2:2014 (Edition 4) was published as DIN EN 60601-1-2:2016 with the title “Electromagnetic disturbances – Requirements and tests.” At the end of 2020, a new version of this “EMC standard” – modified by Amendment 1 and called Edition 4.1 – was published.
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