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qmsWrapper Blog

Take Back Compliance

The Art of Managing Through Quality

Post-market surveillance (PMS) of medical devices

Post-market surveillance (PMS) of medical devices

Let’s try to clear out all the mystery that stands behind this statement. We’ll start with its definition from the previous article where we have defined basic terms in the medical device industry: Medical device manufacturers, as well as other companies involved in the distribution of devices, must follow certain requirements and regulations once devices are...
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What is medical devices lifecycle

What is medical devices lifecycle

The Medical Device life cycle is considered a development of the product, from the very beginning to the end. What is the beginning, what is involved in the middle, and what is considered the end will be explained in this article.
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Cup of Joe #49 – Do You Need A Consultant?

Cup of Joe #49 – Do You Need A Consultant?

With the ever-changing global marketplace of today, medical device companies are feeling the pressure of competition, the pressure to provide the most value and highest quality in their medical products.
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Basic Terms in Medical Device Industry

Basic Terms in Medical Device Industry

We can’t emphasize enough how important is to understand the language of medical devices. To meet the requirements and the Regulations it’s essential to understand what is meant by keywords and phrases.
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QMS Manager role in MedDev industry

QMS Manager role in MedDev industry

A QMS manager safeguards that standards are met throughout all processes of the company, from customer relations to manufacturing processes and all in between.
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The European Commission proposed MDR delay

The European Commission proposed MDR delay

The Medical Device Regulation (MDR) was due to become fully applicable on 26 May 2020. However, the outbreak of COVID-19 has placed unexpected pressures on economic operators, notified bodies and competent authorities.
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NEW MDR: May 2020 postponed

NEW MDR: May 2020 postponed

According to the latest EC news, the MDR deadline may have been postponed. As a result of the disruptions caused by COVID-19.
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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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