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qmsWrapper Blog

Take Back Compliance

The Art of Managing Through Quality

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Understand ISO 13485 - Lesson 1

Understand ISO 13485 - Lesson 1

ISO 13485 for everyone - Simplified, explained, chapter by chapter - quality management system for medical devices! start with lesson 1.
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5 FAQs about ISO 13485

5 FAQs about ISO 13485

What are 5 the most frequently asked questions about ISO 13485? Check the questions, but find out all answers.
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The Wetling Company’s eQMS-journey

The Wetling Company’s eQMS-journey

Read Success Story - how The Wetling Company stayed compliant thanks to their choice when it comes to eQMS. By offering the latest cloud-based eQMS solutions, qmsWarpper is their support in quality.
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Post-market surveillance (PMS) of medical devices

Post-market surveillance (PMS) of medical devices

As the medical device's complexity increases, post-market surveillance is getting more rigorous, so it can lead to earlier detection of potential failure at the end-user. To meet these needs, manufacturers should take a risk-based approach when considering clinical and medical device post-market surveillance requirements.
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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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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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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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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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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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