Whitepapers
MedTech quality and regulatory whitepapers
This page provides Medical Tech quality and regulatory whitepapers with practical guidance on quality, risk, design controls, and regulatory compliance for medical device and SaMD companies. The resources include detailed explanations of ISO 13485 requirements, ISO 14971 risk management practices, FDA QMSR expectations, and EU MDR/IVDR considerations, helping QA/RA professionals understand best practices and regulatory obligations across global markets.
Efficient Team Communication
Efficiently communicate within your team using qmsWrapper's Team Messaging module. Engage in one-on-one chats, group chats, or topic-based discussions, with the ability to send messages,...
Process Engine: A Comprehensive Guide
Understand the process approach in qmsWrapper and how it supports QMS standards. Learn about processes, tasks, and flowcharts to effectively manage workflows. Create and customize...
Introduction to Dashboard
Efficiently manage your work with qmsWrapper's Dashboard. Access your current events, adjust your profile, receive notifications, and navigate through different modules using the Toggle Sidebar.
Users Roles
Learn how to effectively manage user access and permissions in qmsWrapper. Understand user roles, adding users manually or through LDAP, assigning roles, and much more.
Set Up Your Profile
In this guide, users will learn how to set up and personalize their profiles in qmsWrapper. They will discover how to access profile settings, manage...
qmsWrapper with Jira integration
qmsWrapper can be wrapped around Jira. This extends the benefits of Jira in the medical device world. The medical device startups and small businesses that use Jira...
Implementation agenda for setting up the QMS
This document is summarizing the necessary steps of the initial QMS implementation.
Forms in qmsWrapper
A form is a document with a fixed arrangement of input fields, designed for entering, extracting, or communicating the required information. In qmsWrapper, there are:...
qmsWrapper Best Practices – Document Management
In this document, we collected best practices to help you develop advanced document managing skills in qmsWrapper.
