Many regulatory requirements demand that manufacturers define processes and procedures. Such requirements include, for example, EU regulations (MDR and IVDR), standards such as ISO 13485, IEC 62304, and ISO 14971, and the FDA.
Content
On this page, you will find references to articles on processes and procedures:
The description of processes and procedures differs in their level of granularity. Processes describe WHAT is done. Standard operating procedures describe HOW something is done.
However, regulatory requirements do not always distinguish precisely between the two.
All instructions must ultimately determine
The processes and procedures are part of quality management. This overview page provides a helpful introduction to the topic of quality management.
The article on creating process and standard operating procedures is helpful. This should only be the task of the QM representative for selected processes.
Once the processes have been defined, they must be subjected to process validation.
Manufacturers should note the difference between process orientation and process management.
All manufacturers must define a development process. They should understand the boundaries and interactions between the development plan and process to do this.
Many manufacturers use agile development models for software development. On the other hand, documentation should follow a model more akin to the V-model.
Part of development involves risk management or the risk management process. Here, manufacturers must also analyze the risks posed by inadequate processes, for example, with a process FMEA (pFMEA).
The processes must cover the entire life-cycle of the devices:
The Johner Institute helps manufacturers of medical devices to establish lean and standard-compliant processes and procedures.
This enables you to develop and launch your devices quickly and safely in the planned time and at the scheduled cost.
Contact us so that we can draw up a plan together on how you can establish these processes and procedures in a short time and at minimal cost.
FMEA, or Failure Mode and Effect Analysis, is a procedure for investigating the unknown effects of known causes. In the case of medical devices, for example, FMEA is used in risk analysis to analyze the consequences of a faulty component, in particular, the resulting hazards.
DetailsThe QM manual is the top document in the document pyramid of the QM system. It is an entry point for employees and auditors to get a quick overview of the QM system. In this article, you will learn when you need a QM manual, its objectives, and what it should contain.
DetailsThe TIR45 (“Guidance on the use of AGILE practices in the development of medical device software”) is a Technical Information Report (hence TIR) of AAMI, the Association for the Advancement of Medical Instrumentation. First published in 2012, TIR45 has one primary objective: To guide medical device manufacturers on developing software compliant with FDA requirements while…
DetailsTrend analysis is a legal obligation of all medical device manufacturers, especially in “Post-Market Surveillance.” Manufacturers must not fail in the selection and application of suitable statistical methods for trend analysis. This is because the focus of authorities and notified bodies is increasingly shifting to monitoring post-market activities. This article provides a quick introduction to this…
DetailsThe 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…
DetailsMedical 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…
DetailsLaws 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.
DetailsBoth IEC 62304 and the FDA require integration tests.
We frequently get asked, “Do you also offer Computerized Systems Validation?” One of the reasons for the interest is certainly: Authorities and notified bodies increasingly address the Computerized Systems Validation (CSV) in audits. This article introduces regulatory requirements regarding “Computerized Systems Validation” and provides guidance on how you can best meet these requirements.
DetailsIf manufacturers don’t conduct a legally compliant performance evaluation of their in vitro diagnostic medical device (IVD), they aren’t just running the risk of problems during the authorization process: They are risking patient safety. Therefore, the IVDR sets strict requirements for this performance evaluation. Find out how the requirements of the IVDR for the performance…
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