Jira
Confluence
SoftComply Risk Manager is an add-on for Atlassian Jira to manage, trace and report your product risks.
SoftComply Risk Manager Plus is an add-on for Atlassian Jira to manage, trace and report your safety-critical product risks.
SoftComply eQMS is a full medical device Quality Management System developed as an add-on for Atlassian Confluence.
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.
A Feature That Really Stood Out In SoftComply Risk Manager Was The Risk-Line Duplication Tool, This Helps Speed Up Risk Assessments Significantly!
SoftComply Risk Manager Is Professional, Easily Configurable, Intuitive, And Very Relevant To Risk Management. This Is Probably The Better Of Risk Management Add-Ons For JIRA!
The Traceability Features Of SoftComply Risk Manager Are Great, Giving The Ability To Trace Risk Control Implementation And Mitigation!
SoftComply Risk Manager – Overdue, Highly Useful, Risk Management Add-On For Medical Device Software (And Hardware) Development To The ISO 14971 Standard For Those Using JIRA And Confluence.
I Think SoftComply Risk Manager Would Also Be Suitable For Those Doing Safety Critical Software Development In Other Engineering Domains.
The Automated Risk Management Plan And Risk Management Report Generation Into Confluence Is A Great Feature Of SoftComply Risk Manager, This Should Speed Up Our Risk Documentation!
The Ability To Customise The Risk Matrix & Define Risk Levels In SoftComply Risk Manager Is Great!
Love The Summary Report Being Automatically Included In The Risk Matrix!
Re-Use Is A Big Thing And It Is Awesome That With Your Risk Management Add-On, I Can Reuse Mitigations!
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 […]
Read MoreModern 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 […]
Read MoreFMEA 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 […]
Read MoreSoftComply LTD
info@softcomply.com
+372 712 1050
Tallinn Office
Teaduspargi 6/1
Tallinn 12618
Estonia
Munich
Bavariaring 24
Munich 80336
Germany
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.
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.
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.