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qmsWrapper Blog

Take Back Compliance

The Art of Managing Through Quality

10+ essential things what MedDev startups must know

10+ essential things what MedDev startups must know

It is not easy to build a Medical Device. And we all know that every beginning is hard. Therefore, for startups, it’s quite a challenge. But fear not. More you know, easier it is. Since the 2000s, MedDev startups have become more important in the global economy and the business environment is changing accordingly. To survive...
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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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Top 20 Medical Device Conferences and Trade Shows 2019

Top 20 Medical Device Conferences and Trade Shows 2019

The power of trade shows is impressive. From showcasing your newest products, to expand your customer base, close sales, keep an eye on your competition, expand your distributor network, meet face to face with your remote customers, etc.
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