Regulatory Compliance on Atlassian
for FDA approval & CE-marking

Risk Management on JiraJira
for Software Products

Quality Management on ConfluenceConfluence
for Medical Devices

Products

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 153 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.

Some of our customers

Our partners and supporters

Latest blog posts

Hazard Analysis & FME(C)A on Jira – SoftComply Risk Manager PLUS is out now!

02 Nov 2018

We are happy to inform you that our Risk Management solution for Jira has gotten an upgrade for Jira Server users …

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The Importance of IEC 62304 Compliance Part 2

14 Sep 2018

Following up on our first blog post on how to become a trusted software supplier to established medical device manufacturers with the help of IEC 62304 …

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Manual Versioning of Risks with SoftComply Risk Manager

24 Aug 2018

For tracking changes in risk management over time you might want to have versioning of your risk management table and risk reports. In other words …

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Contact us

SoftComply LTD
info@softcomply.com
+372 712 1050

Tallinn Office
Teaduspargi 6/1
Tallinn 12618
Estonia

Munich
Bavariaring 24
Munich 80336
Germany

Dr. Marion Lepmets

Co-Founder & CEO
marion@softcomply.com

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@softcomply.com

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@softcomply.com

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.