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IEC 62304 outlines the guiding principles for the development of medical software. It is the gold standards for medical device companies, but its importance goes beyond legal manufacturers and established medical software suppliers.

In the vast majority of cases, software embedded in a device (or a device itself) use abundant OTS (Off The Shelf) code, not to mention drivers, libraries or other content available for free on the web. All of these fall under the category of SOUP – Software Of Unknown Provenance (or Pedigree). Although the use of SOUP helps significantly the job of developers, it has the opposite effect on the risk management process. A comprehensive risk analysis has to be carried out for each SOUP item, ensuring its behavior poses no threat to the device; furthermore, published bug lists may not be available at all. A big headache.

If you develop software, standalone or embedded, that is used in Medical Devices but is not a device itself, you can decide to apply IEC 62304 on your process.

Yes, it will increase the overhead, the paperwork and possibly somehow slow down the development, but IEC 62304 compliance will give you a significant competitive advantage over other developers.

Although the definition of SOUP is relatively high level, most corporations consider SOUP anything that is not developed per 62304. Finding a certified product may be the make-or-break in the selection of a supplier.

To continue reading about how to become a trusted software supplier to large medtechs, please read on from our most recent blog post.

eurospi workshop on medical devices

Medical Device Workshop on 5.09 in Bilbao!

Join us at the Medical Device Workshop!

on Sept 5th, 2018

in Bilbao

Talks & discussions by industry leaders and academics on the new MDR, Medical SPICE, FDA's Case for Quality - CMMI for medtech industry, Agility in a Regulated World, Risk Management and the IEC 62304. Registration now open!


Visit us at MEDICA 2018 in November in Düsseldorf, Germany!


Benefits of the SoftComply Risk Manager:

▪ Fully customizable for any type of risk project
▪ Automated traceability
▪ Supports FDA approval and CE-marking process
▪ Most competitive price
Fully customizable for any type of risk project
Automated traceability
Supports FDA approval and CE-marking process
Most competitive price

Benefits of the SoftComply eQMS:

▪ Full Quality Management System for medical device co-s
▪ Based on ISO13485, IEC62304, ISO14971 & FDA 21CFR 820
▪ Fully customizable with embedded guidance
▪ Reduces the cost of compliance
Full Quality Management System for medical device co-s
Based on ISO13485, IEC62304, ISO14971 & FDA 21CFR 820
Fully customizable with embedded guidance
Reduces the cost of compliance

SoftComply eQMS on Confluence Cloud:

The new MDR states that Quality System documents need to be searchable. You can now implement a compliant Quality System documentation on your Confluence Cloud! Access the free trial version directly from the Atlassian Marketplace.

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