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White papers - To help you understand

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
Document Management & Control

Document Management & Control

Document Management & Control with qmsWrapper for achieving and maintaining ISO 13485:2016, CE Mark or U.S.QSR (21CFR 820) for 510(K) Compliance Success. What qmsWrapper Document Management System includes? How to organize your files? How to securely store and protect  your Business Data and Compliance Documentation with qmsWrapper you can find out by downloading our whitepaper.

Document Management & Control
Project management with qmsWrapper

Project management with qmsWrapper

New product development success depends on efficient and effective project management. It can be a challenge in smaller companies because typically one person is handling multiple products and multiple teams. How to track, manage and organize your projects and your teams, check on our whitepaper.

Project management with qmsWrapper
Traceability Matrix

Traceability Matrix

An essential criterion for FDA and CE Mark success is Traceability of medical device requirements. Technically referred to as a Requirements Traceability Matrix (RTM), it’s central to the development of safe medical devices as, when it’ s done right, it’s the foundation of your FDA Design History File (DHF) and your CE Mark Technical File...

Traceability Matrix