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Until recently, the Medical Device industry was comprised of a handful of large and well-established hardware manufacturing organizations. As those devices have become more software-driven, so too have software development companies begun working closer with the medical device manufacturers. In addition to supplying software to those manufacturers, these software companies now also independently develop medical products built for consumer devices. Today, the majority of medical device software in the EU is developed by small and medium sized software companies.

The biggest challenge facing fledgling medical device software developers is adhering to the same set of rigorous regulations as the established medical device manufacturers, to ensure that their products are safe to use.

This case study examines the challenges that small-to-medium software companies face when entering the regulated medical device industry, how they can overcome them, and the tools they should use.

To continue reading about how to become compliant on Jira and Confluence with plugins from SoftComply and Comalatech, please read on from our most recent blog post.


Need a compliant Quality System 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.

Medical device workshop at EuroSPI

Medical Device Workshop on 5.09 in Bilbao!

Join us at the Medical Device Workshop!

on Sept 5th, 2018

in Bilbao

Talks & discussions on the new MDR, Medical Device Safety & Security, Risk Management and the FDA's Case for Quality. Registration now open!


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
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