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qmsWrapper Blog

Take Back Compliance

The Art of Managing Through Quality

Medical Device Trade Shows after COVID-19

Medical Device Trade Shows after COVID-19

Based on the trending situation of Coronavirus (COVID-19) and the time when the pandemic is predicted to last, Medical Trade Shows are postponed. We will help you be updated: new dates are available.
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It's Your Own Data

It's Your Own Data

qmsWrapper has a new feature that is helping you to be just one click away from securing your important data to your place!
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Cup of Joe #47 - 2 Risk Modules

Cup of Joe #47 - 2 Risk Modules

A new Risk Analysis Module (RAM), is introduced to help focus on the relationship between requirements, design, and benefits, with emphasis on risk-based design.
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Enterprise-grade Processing Engine

Enterprise-grade Processing Engine

Massive update of the year is happening and qmsWrapper’s Users will be thrilled to find out what is new in one of the 4 upgrades – Process Engine.
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The New Risk Module supports risk-based design

The New Risk Module supports risk-based design

Risk Analysis Module becomes a very important update, next to other features: Traceability Matrix, Process Engine, and Jira integration. Changes will make Risk Assessment much easier and clearer.
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Jira is now “wrapped” with qmsWrapper

Jira is now “wrapped” with qmsWrapper

The combination of JIRA brings a system in which Medical Device Startups are able to track, manage and organise all CE Technical Files and FDA Design History Files, and do it in the most effective manner possible.
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Wrap Jira in QMS

Wrap Jira in QMS

qmsWrapper announces 4 major upgrades. Our new Traceability Matrix as the new dashboard, and with Jira software integration,..., no struggle with FDA and Ce Mark submission.
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How CAPA should be verified?

How CAPA should be verified?

Verifying the effectiveness of corrective and preventive actions (CAPAs) closes the loop between identifying a problem and completing the actions to solve it.
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Cup of Joe 42# - Dealing with CAPA

Cup of Joe 42# - Dealing with CAPA

During the audit process, CAPA is always in the center of attention, and auditors are very strict when it comes to it. Also, failure to stick to proper corrective and preventive actions is considered a violation of regulations on good manufacturing practices.
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Cup of Joe 41# - 4 reasons - why eQMS over paper-based QMS

Cup of Joe 41# - 4 reasons - why eQMS over paper-based QMS

When implementing and maintain ISO standard such as ISO 13485, it is burdensome to maintain paper-based documentation and it’s very time-consuming. It is quite a struggle to find information when needed in the thick of ‘forest’ of document history.
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CAPA Checklist - Step by Step Guide

CAPA Checklist - Step by Step Guide

The purpose of corrective and preventive action is to collect and inspect information, identify and examine product or potential quality problem, then take suitable and effective corrective/preventive action.
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Correct way to follow procedures and processes

Correct way to follow procedures and processes

Every company has as part of its organization set of procedures and processes. The purpose of having procedures is to drive efficiencies towards fewer errors and resulting reworks, which can improve cost saving. Besides that, their purpose is also to make sure they are in compliance with regulations.
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