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 206 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 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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What is Software Tool Validation?

21 Jan 2019

Modern medical device regulations are putting more and more emphasis on the management of software tools. These tools are software packages that are not part of the medical devices themselves, but support the device during its lifecycle. Nowadays companies use dozens of applications, ranging from accounting tools to email clients to software compilers. Of course […]

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What is FMEA?

26 Nov 2018

FMEA stands for Failure Modes and Effects Analysis, it is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. From ISO 14971: “FMEA is a technique by which the consequences of an individual fault mode are systematically identified and evaluated. It is an […]

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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.