Numerous companies struggle to enter medical device domain due to strict regulatory requirements for medical device products. Similarly, large medical device manufacturers have a difficult time finding suppliers that are not only innovative but also compliant with the regulatory requirements of medical device domain at the same time.
A Quality Management System (QMS) is a collection of procedures and processes which describe how your organization carries out the development, distribution and maintenance activities to comply with the applicable standards and regulations. Having a compliant QMS is the basic requirement to enter the medical device market worldwide.
Did you know that about 25-30% of a developer’s time is devoted to generating the documents for regulatory audits in each medical device software project alone? We help medical device companies fast-track the development of their Quality Management System with the help of our Atlassian add-on for Confluence, called the SoftComply eQMS.
The SoftComply eQMS is a Quality Management System packaged as an add-on for Confluence Server. It is based on the requirements of ISO 13485:2016, IEC 62304:2006 (as amended in 2008 and 2015), ISO 14971:2012 and 21 CFR 820, making it applicable for both the EU and the US markets. The SoftComply eQMS will fast-track the development of your organization’s procedures and processes for regulatory compliance.
Benefits of using the SoftComply eQMS:
1. Kick-starts your FDA and ISO-compliant Quality Management System development with ready-made and pre-filled SOPs (15) and templates (47) – all you need to do is add your company and product development details in them!
2. Your QMS is a designated Space in your company’s Confluence – home to all of your QMS related documents!
3. You can easily copy QMS templates from your QMS Space into other project spaces that your company manages and that need to comply with your Quality System requirements – quickly managing the QMS requirements in various projects you run!
4. The QMS Example Space provides a full exemplary QMS of a sample company – your guide to finalizing your own QMS documentation!