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.

Explore More

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.

Explore More

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.

Explore More

SoftComply products are used by 517 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

What is a Risk Management File?

22 Jun 2020

ISO 14971:2019 defines the Risk Management file as a “set of records and other documents that are produced by risk management”. In practice, the risk management file must contain, or have reference to, the following documents: (4.2, Note 3) The policy for establishing criteria for risk acceptability. (4.4) The Risk Management Plan. (4.5) Traceability for […]

Read More

Comparison of SoftComply eQMS & MediCompli Solution

08 May 2020

What is a Quality Management System? You probably know that Medical Device companies are required to have a Quality System in place, in order to be able to market their products in most countries in the world. This Quality System, or Quality Management System – QMS, is a collation of Procedures, documents, templates and records […]

Read More

How to Create an Organisational Risk Register with SoftComply Risk Manager?

04 May 2020

Abstract The aim of this blog post is to guide you through the creation of an organisation-wide Risk Register with SoftComply Risk Manager. This Risk Register supports risk management across your organisation providing your team members with a list of risks that apply to a specific product or project. To achieve that, we will first […]

Read More

Contact us

SoftComply LTD
info@softcomply.com
+372 5303 9216

Tallinn Office
Teaduspargi 6/1
Tallinn 12618
Estonia

Munich Office
Bavariaring 24
Munich 80336
Germany