Product Information
What is Qmswrapper?
qmsWrapper is an intelligent management software that effectively avoids adding another layer of administration by encouraging team-based collaborative compliance.
It assists all companies looking to effortlessly achieve and manage ISO 13485:2016 and 21 CFR 820, as well as those aiming for ISO 9001:2015 and medical device creators.
This software is designed for any company in need of a robust and unified platform to enhance team collaboration more efficiently. qmsWrapper integrates quality, documentation, project and risk management, along with team communication—all inherently built into its DNA. Explore all our features: https://www.qmsWrapper.com/features
Who is it for?
For companies requiring guidance to implement and adopt a validated QMS.
For businesses seeking to automate their quality management and move beyond paper-based systems.
Integration with Jira
This integration helps medical device companies combine the best agile development system with the best QMS system.
Choose your QMS:
EQM for MEDDEV
EQM: ISO 9001
Basic package includes:
25 users + 1GB storage
Additional storage available up to 500GB.
$18.00 per 1GB
Free manual
How to use Qmswrapper?
qmsWrapper is an intelligent management software providing startups and SMBs with a connected quality management system (QMS) that integrates quality, documentation, project, risk management, and team communication to enhance productivity and meet ISO 9001, ISO 13485, and other compliance requirements.
Core Functions of Qmswrapper
Optimal Performance
Gantt Chart
Team collaboration
Document Management System
Team Management
Risk Management
Usage Scenarios of Qmswrapper
- Companies needing guidance to implement and adopt a proven Quality Management System (QMS).
- Companies looking to automate quality management and move away from paper-based systems.
- Medical device companies needing to meet FDA, ISO 13485, and 510(k) submission requirements.
- Automate quality processes like CAPA, deviations, complaints, change control, and training.
- Manage projects, documentation, risks, and team communication.
- Comply with regulatory requirements such as FDA, ISO, MDR, HIPAA, and GDPR.
Common Questions about Qmswrapper
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