SoftComply Ltd. of Tallinn at MEDICA 2017 in Düsseldorf -- COMPAMED Trade Fair
Service

SoftComply Ltd.

Teaduspargi 6/1, 12618 Tallinn
Estonia

Telephone +372 530 39216
info@softcomply.com

This company is co-exhibitor of
MEDICA Start-up Park - Messe Düsseldorf GmbH

Hall map

MEDICA 2017 hall map (Hall 15): stand B57-7

Fairground map

MEDICA 2017 fairground map: Hall 15

Our range of products

Product categories

  • 06  Information and communication technology
  • 06.01  Archiving and documentation

Archiving and documentation

  • 06  Information and communication technology
  • 06.01  Archiving and documentation
  • 06.01.01  Systems for medical documentation, document management

Systems for medical documentation, document management

  • 06  Information and communication technology
  • 06.02  IT infrastructure / computer hardware / mHealth

IT infrastructure / computer hardware / mHealth

  • 06  Information and communication technology
  • 06.02  IT infrastructure / computer hardware / mHealth
  • 06.02.05  Cloud computing
  • 06  Information and communication technology
  • 06.04  Administrative information systems / software

Administrative information systems / software

  • 06  Information and communication technology
  • 06.04  Administrative information systems / software
  • 06.04.05  Software for manufacturers of medical products

Software for manufacturers of medical products

  • 06  Information and communication technology
  • 06.04  Administrative information systems / software
  • 06.04.24  Tools, utilities, standard software, interfaces

Tools, utilities, standard software, interfaces

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies

Technical equipment management, Test houses / Certification Bodies

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies
  • 07.10.02  Certification and testing of medical devices, quality assurance

Certification and testing of medical devices, quality assurance

Our products

Product category: Archiving and documentation, Systems for medical documentation, document management, IT infrastructure / computer hardware / mHealth, Cloud computing, Administrative information systems / software, Software for manufacturers of medical products, Tools, utilities, standard software, interfaces, Technical equipment management, Test houses / Certification Bodies, Certification and testing of medical devices, quality assurance

SoftComply Risk Manager

Looking for Risk Management for Jira?
SoftComply Risk Manager is an add-on for Atlassian Jira to manage, trace and report your product risks. Fully customizable and integrated to Atlassian Jira, available for both Jira Cloud and Jira Server.

FEATURES:

Customizable
SoftComply Risk Manager is a Risk Management add-on that is fully customizable to any risk management method or approach, e.g. FMEA or Hazard Analysis, used in safety-critical product development like medical devices.

Integration
SoftComply Risk Manager is fully integrated to Atlassian JIRA.

Traceability
SoftComply Risk Manager records links between risks, requirements, test cases and other risks for traceability and audit trails.

Reporting
Automated generation of pre-filled and tailorable Risk Reports (Risk Management Plan and Risk Management Report) including the visualization of risks in Initial and Residual Risk Matrices.

BENEFITS:
Supports FDA and CE-marking
SoftComply Risk Manager is based on ISO 14971:2012; and IEC 62304:2006 thus comprehensively focusing on the EU and USA markets.

Specifically for Product Risk Management for Jira
SoftComply Risk Manager isthe only risk management add-on for JIRA specifically developed for your product risk management.

First Risk Management add-on for Jira Cloud
SoftComply Risk Manager is the first risk management add-on for Jira Cloud.

Familiar interface for Risk Managers
SoftComply Risk Manager has the familiar yet customizable interface for risk management.

Most Competitive Price
Get SoftComply Risk Manager from as low as $50 per month from Atlassian Marketplace.

The majority of our clients are from USA, UK, rest of Europe & they include startups as well as Fortune 500 companies.

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Product category: Archiving and documentation, Systems for medical documentation, document management, IT infrastructure / computer hardware / mHealth, Cloud computing, Administrative information systems / software, Software for manufacturers of medical products, Tools, utilities, standard software, interfaces, Technical equipment management, Test houses / Certification Bodies, Certification and testing of medical devices, quality assurance

SoftComply eQMS

FEATURES:

Full Quality Management System
SoftComply eQMS has a Quality Manual, a Quality Policy, 17 SOPs and 45 document templates pre-filled to fast-track the development and implementation of your QMS. Just add your company and product development details!

Customizable
SoftComply eQMS is fully customizable to any medical device development project.

Integration
SoftComply eQMS is fully integrated to Atlassian Confluence.

Embedded Guidance
SoftComply eQMS contains embedded guidance on how to customize the SOPs and technical documents according to your company and the device.

Full Example QMS
SoftComply eQMS contains a completed Quality Management System, an Example QMS, of a made-up company and its device, illustrating how to customize the SoftComply eQMS for your specific needs.

Compliance in all projects
SoftComply eQMS provides a home for all QMS documentation as a space in Atlassian Confluence. You can easily copy QMS templates into other project spaces that need to comply with your Quality System requirements – quickly managing the QMS requirements in various projects you run!

BENEFITS:

Supports FDA and CE-marking
SoftComply eQMS is comprehensively focused on the EU and US markets helping users fulfill their requirements for ISO 13485, IEC 62304, ISO 14971, 21 CFR 820.

First Quality Management System add-on for Atlassian
Your QMS is a designated Space in your company’s Confluence – home to all of your QMS related documents.

Reduces the Cost of Compliance
The SoftComply eQMS comes with a full sample QMS that provides a full exemplary QMS of a sample company – your guide to finalizing your own QMS documentation.

 

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About us

Company details

About us

We have extensive knowledge and expertise in software development and regulatory affairs in the domain of medical devices.
Our team is located in Ireland and in Estonia.
The majority of our clients are from USA, UK, rest of Europe and they include start-ups as well as Fortune 500 companies.

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