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IEC 62304 applies to medical device development when software is an integral component to medical device production. It defines the software lifecycle when the software stands alone as a medical device (commonly referred to as software as a medical device, or SaMD), is a component of a medical device, or is used in the production of a medical device.
Iec 62304 Pdf Download Free
IEC 62304 is an internationally harmonized standard for medical device software lifecycle processes, recognized by FDA and other regulatory agencies across the world. IEC 62304 provides guidance to the manufacturer on planning, development, and postmarket surveillance activities for medical device software to ensure companies are in compliance with both U.S. and other international regulatory requirements.
An earlier release of IEC 62304 was less clear, but a 2006 amendment to the standard clarifies the requirements. IEC 62304:2006 provides guidance to manufacturers on how to identify hazards that could arise from software failure or defect, in order to properly classify the risk of a medical device. Based on the device risk classification, IEC 62304 provides guidance for risk control measures that must occur throughout the life cycle of that particular device.
This classification scale helps the manufacturer to identify the safety-related processes needed throughout the lifecycle of the medical device software. The applicable requirements are specific to the development and coding, release, and maintenance of medical device software. They are codified in the components of IEC 62304.
The best approach to medical device software development is risk-based, structured and methodical. Traceability throughout the lifecycle of medical device software is key to ensure compliance with IEC 62304.
IEC 62304 is an international standard for medical device software that defines the framework for processes that occur across the lifecycle of the device and software. Requirements from this standard apply whenever software is an integral component of the device, is used in the production of the device, or if it is the device (Software as a Medical Device or SaMD).
The IEC 62304 standard is harmonized internationally and is recognized by the FDA, Health Canada, the European Commission and other regulatory authorities worldwide. It provides guidance for the planning, development and post-market surveillance activities for medical device software.
Risk control measures form a key part of the IEC 62304 standard. When you consider software, you need to consider any potential risk factors related to software failure, software reconfiguration and validation, and, of course, data protection and cybersecurity.
If you are developing medical device software to be sold on the US market, you will need to comply with the corresponding FDA requirements. A good general rule of thumb is to work toward satisfying IEC 62304 requirements first, then apply the necessary FDA requirements.
Another common classification question is, who decides whether certain software should be classified as a medical device? The IEC 62304 standard ultimately places the burden on the manufacturer to make that determination. This can be done by following the applicable guidelines, supporting whichever decision is made with evidence as to why the software should be classified as such.
The first step of IEC 62304 compliance is to carefully plan the tasks needed for successful software development of the medical device. This should involve reducing risks, creating a system design, and defining procedures. You will need detailed documentation to prove that the applicable IEC 62304 requirements have been met.
Compliance with IEC 62304 requires verification and testing activities to be carried out by the manufacturer. At a general level, you need to establish a testing protocol that shows how design outputs meet design inputs.
Traceability of your medical device software design, manufacturing, and post-market activities is a key compliance requirement of IEC 62304. You need a robust, industry-specific QMS that will allow you to easily view and manage all relevant data throughout the life cycle of your medical device software.
Greenlight Guru makes compliance with IEC 62304 as simple as possible by giving users a birds eye view of their quality system to fully understand the relationships between all of its components and easily achieve full traceability.
The definition of SOUP, and the requirements related to their lifecycle in IEC 62304 processes, are totally independent of any technology. Making no technological assumption, that's the way the standard is thought, so that it can be applied to any health software.Cloud-based applications and web technologies make an intensive use of SOUPs. Let's see how IEC 62304 requirements can be applied to these technologies.
The second version of IEC 62304 is still in draft. It has been is this state for almost five years, since the publication of the amendment 1. It is now in public review (or has been in public review in your country) under the name IEC 62304:2019 CDV. Go to the website of your national standardization organization, to see if you can still download it for free!
We had in a previous article an overview of IEC 82304-1 Health software -- Part 1: General requirements for product safety, its scope and its relationships with other standards like IEC 62304.This article presents more in details (but not too much, we're not going to rephrase the standard) the requirements of IEC 82304-1.
The new version of IEC 62304, also known as IEC 62304:2015 or amendment 1 of IEC 62304 was published by the IEC at the end of June 2015.There were no major changes compared to the drafts that were circulated earlier this year.The two major new requirements, compared to IEC 62304:2006 are:
IEC 62304:2015 is available on IEC website at the astounding / amazing / appealing / astonishing (delete as appropriate) price of 650 swiss francs (approx. US$700) for the consolidated version.Enjoy!Now we need to wait for this version to be harmonized by EU and recognized by the USA.
Georg Heidenreich, one of the author of the Frequently Asked Questions on IEC 62304 published on the Team NB website, posted two weeks ago an article about the upcoming updates in the first amendment of IEC 62304.
In the last article we've seen the consequences of regulations on Apps, which run on smartphone or - more broadly - on mobile platforms.Today, let's have a look at the main standard to apply when developing software for medical devices: IEC 62304, and the context in which most people want to apply it: agile methods.
The IEC 62304 standard calls out certain cautions on using software, particularly SOUP (software of unknown pedigree or provenance). The standard spells out a risk-based decision model on when the use of SOUP is acceptable, and defines testing requirements for SOUP to support a rationale on why such software should be used.
Do you want to build safety systems? Do you want to safety-certify an embedded product with complex software? Safety certification demonstrates compliance with a safety standard such as IEC 61508, the basic functional safety standard for electrical, electronic and programmable electronic safety-related systems, and industry-specific standards such as IEC 62304 for medical devices, ISO 26262 for vehicles, IEC 60880 for nuclear power plants, EN 50128/50129 for rail systems and ISO 25119 for agricultural and forestry equipment.
An aspect of functional safety is designing the system to isolate safety-critical functions from other functions and ensure they are free from interference. For example, the important warning displays on an automobile digital instrument cluster should be isolated from vehicle infotainment systems even if they share display space on the dashboard.
A microkernel architecture, such as QNX Neutrino Real-Time Operating System (RTOS) can separate multiple functions, both spatially and temporally, and provide isolation and freedom from interference in embedded systems with mixed criticality.
BlackBerry QNX has developed in-depth safety expertise and technology. In addition, having certified our own products to the highest levels of ISO 26262 (ASIL D) and IEC 61508 (SIL 3), as well as IEC 62304, we have the tools and experience to help get your embedded product across the finish line, too.
Standard specific Cantata tool certification kits are provided free of charge and contain everything needed out-of-the-box as well as comprehensive guidance to help you achieve certification for your device software.Tool qualification kits of Cantata are also available where tool certification against a standard is not permitted as the tool must be qualified separately for each project (e.g. for DO-178B/C).
The Regulatory Documentation Manager (RDM) is a set of templates and python scripts which are designed to help automate IEC62304 compliance as much as possible. At its core, IEC62304 is all about using best practices to build high-quality software that has considered and mitigated as many risks as possible.
There is a method called Model-Based Design by MathWorks which helps to integrate and automate most of the V&V processes required by the IEC 62304 for medical software development. In this way you can fulfil the steps all the way from requirements management to software integration and testing. The documentation artefacts required by the standard are automatically generated in the process.
Model-Based Design incorporates verification and validation into the software development workflow. As a result, the software is comprehensively tested and verified before you integrate it into a medical device. In addition, parts of the documentation required by IEC 62304 are automatically generated for regulatory compliance.