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 244 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

IEC 60601 – Essential Performance, Safety and Risk Management

13 May 2019

IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment. Although if focuses primarily on electromechanical devices, it also applies to aspects of the software components. It is a widely recognized standard that most, if not all, medical device companies have to comply with. The concept of […]

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New Features of SoftComply Risk Manager and Risk Manager Plus for Jira Server Users

25 Mar 2019

We are happy to introduce to you a few new features of the SoftComply Risk Manager Plus and SoftComply Risk Manager Server version. User-Enabled Sorting of Data in the Risk Management Table Data in the risk management table has so far been automatically sorted – the sorting algorithm starts from the left most column in […]

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How to control your electronic Quality Management System in Confluence

19 Feb 2019

In order to have a safe, traceable and manageable Quality Management System in Confluence we need to first take care of our user management. Controlled actions performed by the right people is the cornerstone of developing a safe product. Let’s first review a few definitions, we will then describe the goal of Quality Management System […]

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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.