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:

  1. Articles on processes and activities in the device life-cycle
  2. Articles on the IEC 60601-1 family and physical safety
  3. 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

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 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!