Looking for Software Product Risk Management on Jira?

SoftComply Risk Manager is an add-on for Atlassian Jira to manage, trace and report your product risks.

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Looking for Safety-Critical Product Risk Management on Jira?

SoftComply Risk Manager Plus is an add-on for Atlassian Jira to manage, trace and report your safety-critical product risks.

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Looking for a compliant medical device Quality Management System on Confluence?

SoftComply eQMS is a full medical device Quality Management System developed as an add-on for Atlassian Confluence.

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SoftComply products are used by 307 companies

What our clients say about us

The majority of our clients are in the USA, the UK & the rest of the Europe – they include start-ups as well as Fortune 500 companies.

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Latest blog posts

Cybersecurity in Medical Devices

30 Oct 2019

As software is becoming more and more integral to Medical Devices, new opportunities arise from their networking and data exchange. But this is also exposing them to the same risks as common objects such as laptops and smartphones, i.e. unauthorized access to the device. Although the FDA β€œis not aware of any patient injuries or […]

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How to Set Jira Notifications for Risk Management? Must-Have Tips for Risk Managers!

25 Sep 2019

As you probably know by now Jira is the most customizable issue and project tracking software on the market. It is so flexible, in fact, that sometimes a simple feature might be forgotten or some things are not always easy to find. Today we will explain and provide practical tips on how to set and […]

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How SoftComply eQMS helped speed up the CE-marking of munevo DRIVE – a Case Study

25 Sep 2019

“If you are developing medical device software and need to go through the certification process, look what SoftComply has to offer!”, says Claudiu, the co-founder and CEO of Munevo. Munevo is the company behind munevo DRIVE – the first wheelchair control system that uses smart glasses enabling people to become more independent and safely drive […]

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Contact us

SoftComply LTD
+372 712 1050

Tallinn Office
Teaduspargi 6/1
Tallinn 12618

Bavariaring 24
Munich 80336

Dr. Marion Lepmets

Co-Founder & CEO

Marion has an extensive academic background in medical device software development, she has been a member of international standards working groups & has co-authored IEC TR 80002-3.

Margus Nael

Co-founder & VP of Engineering / CTO

Margus is an expert in Atlassian tools with outstanding industry experience in managing agile software teams in a number of companies, including Skype.

Matteo Gubellini

Co-founder & VP of Regulatory Affairs /
Chief Regulatory Officer

Matteo is an expert in Regulatory Affairs and Quality Management Systems in the medical device field with vast industry experience from several global medical device companies.