Whitepapers

Whitepapers


qmsWrapper's Free QMS Whitepapers on QMS - Gain In-Depth Knowledge about MedDev and ISO 9001 Compliance - Unlock Valuable Insights.

Discover Traceability Matrix and Risk Management Integration, Effective Team Communication, Process Engine, User Roles Management, and more by downloading our educational whitepapers.

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Traceability Matrix and Risk Module

Traceability Matrix and Risk Module

Track the development of your medical device through the Traceability Matrix (TM). Find out how to use TM together with the Risk module in qmsWrapper.

Traceability Matrix and Risk Module
Efficient Team Communication

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, attachments, schedule meetings, etc.

Efficient Team Communication
Process Engine: A Comprehensive Guide

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 processes, use advanced actions, and track progress through the Process Engine.

Process Engine: A Comprehensive Guide
Introduction to Dashboard

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. 

Introduction to Dashboard
Users Roles

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.

Users Roles
Set Up Your Profile

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 their status, download the desktop app, and customize preferences such as display, notifications, and more.

Set Up Your Profile
qmsWrapper with Jira integration

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 can be linked to qmsWrapper.

qmsWrapper with Jira integration
Implementation agenda for setting up the QMS

Implementation agenda for setting up the QMS

This document is summarizing the necessary steps of the initial QMS implementation. 

Implementation agenda for setting up the QMS
Forms in qmsWrapper

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: General Forms, Custom Forms, and Matrix forms

Forms in qmsWrapper
qmsWrapper Best Practices - Document Management

qmsWrapper Best Practices - Document Management

In this document, we collected best practices to help you develop advanced document managing skills in qmsWrapper.

qmsWrapper Best Practices - Document Management
Remote Audit

Remote Audit

Do remote audits becoming ‘new normal’? What are the benefits of remote auditing and what are their limitations? About all that and more, you can find out in our whitepaper.

Remote Audit
Risk Management as ISO 14971 requires

Risk Management as ISO 14971 requires

qmsWrapper recognizes how better quality data is important for decision making. Why is it important to think about risk management as a process and how you can increase the effectiveness of your business through QMS software - you will find in this white paper.

Risk Management as ISO 14971 requires
Quality Management System

Quality Management System

Today the marketplace is overladen and that makes it very competitive, especially for small businesses. Quality services or products can make small businesses not only to survive but prosper. A well-managed QMS is paramount to success! Find out what are the benefits of the QMS implementation in qmsWrapper.

Quality Management System
Supported ISO 9001 and the new clause Hail Mary Pass

Supported ISO 9001 and the new clause Hail Mary Pass

qmsWrapper recognized the client's needs and specific requirements. qmsWrapper is now pleased to announce a newly added version that completely covers and supports ISO 9001:2015. Additionally, We’ve taken the unprecedented step of protecting you, our customers, with an innovative new approach to the license – we’ve added a “Hail Mary” clause.

Supported ISO 9001 and the new clause Hail Mary Pass
Checklist for implementing a QMS for ISO 9001-2015

Checklist for implementing a QMS for ISO 9001-2015

ISO 9001 is a process standard for a quality management system, known worldwide. This standard is suitable for any size company or organization that wants to meet its customers ’ and regulatory requirements and consistently improve.

Checklist for implementing a QMS for ISO 9001-2015
Things to know before you buy qmsWrapper

Things to know before you buy qmsWrapper

A good quality management system is a must. The selection of the proper quality management system software is critical to the success of any company. Picking the wrong one, the company may experience a long implementation. We’ll help you to understand why qmsWrapper is the best choice for your company.

Things to know before you buy qmsWrapper
eQMS validation

eQMS validation

Validation of software is an important and obligatory part of the process when you are using eQMS. It is a process of evaluating software product, to ensure that the software meets customers’ demands and expectations. For more, read on our whitepaper…

eQMS validation
Data Security

Data Security

qmsWrapper cares about its clients on many levels. One of them is Data Security. Data security is a term for ensuring data to stay protected from unauthorized access, change, use or destruction.

Data Security
The Dual Nature of qmsWrapper

The Dual Nature of qmsWrapper

Medical Device developers must have Risk Assessment and they need Traceability, too. It helps them prove compliance and deliver quality products that are safe for patient use. Find out why is Risk Control shown through Traceability Matrix in qmsWrapper.

The Dual Nature of qmsWrapper
The new version you've been waiting for - v 6.0

The new version you've been waiting for - v 6.0

New version 6.0 of qmsWrapper is finally out and brings us 4 major updates: Integration with Jira Software, upgraded Traceability Matrix, New Risk Module, and Process Engine. What are the benefits and why is now a perfect time for subscribing to the best QMS software for medical device startups find out on our white paper.

The new version you've been waiting for - v 6.0
Project & Quality Management System

Project & Quality Management System

An innovative and novel approach to quality and compliance can best be expressed as management through quality compliance as opposed to quality management. Management through quality compliance is different because the focus is not on quality as the end game, but rather on quality as the process to achieve compliance. Find out more…

Project & Quality Management System
QMS for Beginners

QMS for Beginners

Whether you are freshly minted into the QMS position or the founder of a Medical Device Startup, you’re reading this because your strategy requires QMS oversight and your first question is likely “where to start?” Download this checklist.

QMS for Beginners
Checklist for implementing a QMS for ISO 13485-2016

Checklist for implementing a QMS for ISO 13485-2016

There is a lot of information on the Web about implementing a QMS for ISO 13485, but not all very helpful. The danger resides in fluff internet info pieces, written for promotional purposes. If you do QMS right, it’s not a burden, not an added layer of management that gets in the way. The following...

Checklist for implementing a QMS for ISO 13485-2016
Team Collaboration

Team Collaboration

Have your team ever struggled to collaborate successfully in real-time or online? Nowadays, working together remotely is a necessity for most teams and companies. Built-in Team Messaging is designed to Support Team Compliance. Check what Team Messaging offers to you.

Team Collaboration
Quality Manual

Quality Manual

QmsWrapper includes an Interactive Quality Manual Creator Tool that helps you create your company’s Quality Manual, that is fully integrated with your QMS processes or workflows, all in accordance with ISO 13485:2016 and U.S.QSR (21CFR 820). Read more…

Quality Manual