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!
For a number of Medical Device companies, Christmas arrived earlier in 2019. On the 17th December 2019, the second Corrigendum to the Medical Device Regulations was formally approved. This has interesting consequences for some Class I devices, that until now would have had to go through the full rigour of the MDR as of the […]
Read MoreDemonstrating equivalence to an existing, marketed medical device has always been a practical way to show that a new device is safe and effective, and lengthy clinical trials are not required. Now, the “new” EU MDR introduce a new variation in the concept of “equivalence” for medical devices. Annex XIV, Part A, Clinical Evaluation lists […]
Read MoreAs software is becoming more and more integral to Medical Devices, new opportunities arise from their networking and data exchange. But this is also exposing them to the same risks as common objects such as laptops and smartphones, i.e. unauthorized access to the device. Although the FDA “is not aware of any patient injuries or […]
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.
