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 255 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

How to Manage Safety-Critical Product Risks in Jira – New Features of SoftComply Risk Manager and Risk Manager Plus

22 Aug 2019

Risk management is a regulatory requirement for safety-critical products. Without compliant risk management most of these products cannot reach their users. With more and more software in safety critical products like medical devices or cars, software developers now also have to manage the risks during the development to ensure the safety of these products. The […]

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How to Set Page Level Restrictions in Confluence?

15 Jul 2019

In our previous blog posts we have described the Confluence Server level access and Space access and will focus on page level restrictions in this blog post. You can get lots of benefits while knowing a few simple tricks about page restrictions. What are page restrictions and why should I use it? According to Atlassian, […]

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How to Secure your Documents in Confluence?

24 Jun 2019

This short post will provide you insight into taking control over your document management in Confluence Server. This post is not going to touch regular security policies like VPN, firewalls, security policies and ohter things that are outside of the Confluence Server. In other words, all the really technical things are left out and we […]

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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.