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.
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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.
Software maintenance is the phase in which software is further developed, e.g., with the objective of According to the FDA, 79% of all bugs occur during software maintenance. Accordingly, some regulations address this topic. Update: Addition to software maintenance during development Regulatory requirements for software maintenance Requirements of the Medical Device Regulation MDR (2017/745) The…
DetailsThe EU regulations place high requirements on the so-called placing on the market of medical devices. Find out in this article what these regulations mean by placing on the market, what misunderstandings and contradictions you must be aware of, and what requirements manufacturers and devices must meet. 1. Placing on the market: Basics a) Definition…
DetailsThe digitalization of the production is an essential part of the digital transformation of manufacturing companies. However, not all companies benefit to the same extent from digitalization. This article describes, 1. What is the digitalization of the production? The digitalization of the production covers two areas: 2. Why is the digitalization of the production important?…
DetailsThe risk management plan is one of the most important documents in technical documentation. Accordingly, authorities and notified bodies examine this plan intensively. However, it is not only from a regulatory perspective that medical device manufacturers benefit from a precise risk management plan. This article 1. What a risk management plan is In a risk…
DetailsFMEA, 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. 1. How to use the FMEA a) During development Use…
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. 1. QM manual:…
DetailsIn a Standard Operating Procedure (SOP), companies define their processes, for example how they develop medical devices or provide services. Standards such as ISO 9001 and ISO 13485 require Standard Operating Procedures. Companies can define these specifications in their quality management manual directly or in independent documents. 1. Standard Operating Procedures: introduction, definitions a) Definition ISO…
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 MDR and IVDR, as well as ISO 13485:2016, just like the FDA, set out clear requirements regarding supplier evaluation, supplier selection, and supplier monitoring. This article not only gives you an overview of the regulatory requirements. It also gives you tips on how to implement them and tells you when a supplier audit is necessary. 1. Basics of supplier management a) Examples…
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