Hazard and hazardous situation
ISO 14971 defines the terms “hazard” and “hazardous situation.” Nevertheless, medical device manufacturers often find it difficult to assign concrete cases to either of the two categories. This article provides help.
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:
- Articles on processes and procedures in general
- Articles on individual processes and procedures
- Information on support for processes and procedures
1. Articles on processes and procedures in general
a) Differentiation between process instructions and standard operating 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
- who does what, when, in what order, and how
- and which input is converted into which output.
b) Articles
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.
2. Articles on individual processes and procedures
a) Development
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).
b) Post-production phase
The processes must cover the entire life-cycle of the devices:
- Processes in the post-production phase
- Problem-solving process for software
- Corrective and preventive actions (CAPA)
3. Support
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.
CAPA: Corrective and Preventive Actions
What MDR and IVDR confuse and why you should not talk about CAPA. The FDA (in 21 CFR part 820 – QSR) and ISO 13485 differentiate between Unfortunately, the MDR and IVDR do not clearly differentiate between these concepts. Some manufacturers also believe they can combine corrective and preventive actions into one single CAPA process. But…
DetailsUnderstanding and avoiding deviations and nonconformities
Deviations, nonconformities, errors, findings, observations, and other terms are often used mistakenly synonymously. Even standards explicitly contradict each other when defining individual terms. This article clarifies,
DetailsRisk management in hospitals and at other operators
Laws require risk management in hospitals, especially in order to improve patient safety. Nevertheless, many hospitals find this difficult. This article presents the most important regulatory requirements and provides tips for implementation.
DetailsQMSR: The end of 21 CFR part 820?
In 21 CFR part 820, the FDA formulates the requirements for the quality management systems of medical device manufacturers, among others. Thus, 21 CFR part 820 (Quality System Regulation QSR) is or was the counterpart to ISO 13485.
Software life cycle: What is meant by this?
The Medical Device Regulation (MDR) (like the Medical Device Directive (MDD) and thus the Medical Device Act before it) requires manufacturers to comply with life cycle processes for their software. IEC 62304 and IEC 82304 also refer to software life cycle processes. But what is a software life cycle?
Software maintenance: How to avoid typical audit pitfalls
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.
DetailsPlacing on the market: Definition and regulatory requirements
The 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.
DetailsDigitalization of the production
The 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,
DetailsRisk management plan: The most important advantages
The 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
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