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qmsWrapper team
Cup of Joe #46 - New superpower for MedDev through qmsWrappers TM

Cup of Joe #46 - New superpower for MedDev through qmsWrappers TM

Last week qmsWrapper announced the greatest upgrade of the year. New updates are Integration with Jira Software, updated Risk Module, and Process Engine and, best for the last - upgraded Traceability Matrix! Joe will introduce you to the first one of the super upgraded Traceability Matrix. Traceability Matrix with an issue Working in TM in the past had a...
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Wrap Jira in QMS

Wrap Jira in QMS

27th November 2019 Toronto, CA - QmsWrapper, a world-famous QMS System that helps Meddev startups and small businesses achieve and manage ISO 13485:2016 and 21 CFR 820, announces that the future is now available with the latest release where vision meets functionality.  Vs6.0 will radically change the way you look at QMS. It moves away from being...
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Top 10 medical device trade shows 2020 not to be missed

Top 10 medical device trade shows 2020 not to be missed

Tradeshows are an excellent opportunity for exhibiting the newest products and any kind of innovation that your company has made.  It’s perfect for brand awareness, as well, as for promoting your business. There is so much benefit to attend a trade show. We have listed 10 trade shows in the world for 2020, which we believe has...
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Cup of Joe #45 - How to choose a good manufacturer?

Cup of Joe #45 - How to choose a good manufacturer?

Before making any big decision, it’s always recommendable to think it through. It’s not an easy task to find a good outsourced manufacturer for your needs, for your medical device that should conquer the market. Especially if you don’t know much about the technical part but you are aware of what your product’s requirements are, getting...
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THE NEW MDR 2020 – all you need to know

THE NEW MDR 2020 – all you need to know

  TO ALL MEDICAL DEVICE MANUFACTURERS   The New regulation (not directive anymore) is knocking on a door to Medical Device manufacturers. Transition time is running out, it’s just 6 months away. Are you ready? We will give you a few handy pieces of information that will provide you a clearer image of what is requested and help you go...
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How CAPA should be verified?

How CAPA should be verified?

“Efficiency without Effectiveness misses the Purpose Effectiveness without Efficiency misses all the Profit Effectiveness with Efficiency brings Performance.” ― Martin U.  Ugwu   Verifying the effectiveness of corrective and preventive actions (CAPAs) closes the loop between identifying a problem and completing the actions to solve it. Reminder: The main purpose of corrective and preventive actions (CAPA) is to improve the organization processes...
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4 steps how to carry out RCA

4 steps how to carry out RCA

Why? Where? How? When? What? Most problems don’t have obvious solutions. That’s why they remain problems, and that’s why, it’s necessary to be aware of underlying causes, especially when planning to carry out a root cause analysis. Root cause analysis is basically a process with a systematic approach for identifying a problem. It provides companies a way to prevent...
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Cup of Joe 43# - Treat the cause, not the symptom

Cup of Joe 43# - Treat the cause, not the symptom

What is the root cause analysis? Root Cause Analysis is something that we all do when we want to solve a problem for good. But what RCA actually means? It means to find what caused the problem, to find out not only what went wrong in the beginning, but how, when and why as well. Basically, RCA is...
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Cup of Joe 42# - Dealing with CAPA

Cup of Joe 42# - Dealing with CAPA

CAPA is a system that consists of improvements taken to eliminate the causes of non-conformities or any other undesirable situation within an organization’s process. Every company should develop a strategy for CAPA as part of its overall quality system. To manage the suitable CAPA activity, it is important to track, manage and evaluate all different quality data...
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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. Good organization is essential for a guaranteed successful business. There are few reasons for choosing an eQMS...
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CAPA Checklist - Step by Step Guide

CAPA Checklist - Step by Step Guide

CAPA – Corrective action Preventive action 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. It’s a process of improvement taken to eliminate causes of possible malfunction, problem or another unwanted situation.  It’s also a process which auditor...
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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. The procedure is correct, but are the follow-ups...
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Cup of Joe 40# - Documents and procedures amendment

Cup of Joe 40# - Documents and procedures amendment

It's one thing to become ISO certified, but maintaining the certification is another thing with all the updates and new records. Besides following the processes and procedures that were set, it's also required to improve processes and all recorded as evidence. That means keeping up with your documentation, updating procedures when the processes change, modify work...
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Cup of Joe 39# - Key factor during an audit–prepared employees

Cup of Joe 39# - Key factor during an audit–prepared employees

A successful audit relies on communication. So, the preparation of employees in order to know exactly how to interact with the auditors when they arrive is one of the most important steps. This means Meeting! If the staff members are able to work collaboratively with the auditors, the audit will be conducted more efficiently, and...
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Cup of Joe 38# - There is such a thing like painless audit?

Cup of Joe 38# - There is such a thing like painless audit?

An audit is verification of activities – process or quality system in order to ensure compliance to some requirements. As such audits always generate tension and anxiety – because you know that some stranger is coming to check your work and could give you a failing grade! Painless = prepared, the more prepared, the more painless. Standard...
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Cup of Joe 37# - Why we have to perform an audit?

Cup of Joe 37# - Why we have to perform an audit?

At work, nothing raises the hairs on the back of your neck like the word “audit”. Audits mean fault, mistake, short-coming and blame, fault, culpability all wrapped in disappointment – you have failed!  The bullies incorporate love them! But the wise manager embraced them and uses them to pre-empt the bullies, by self-auditing.   The more positive...
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Cup of Joe 36# - Scary word “Audit”

Cup of Joe 36# - Scary word “Audit”

An Audit is the on-site verification activity of a process or quality system, to ensure compliance to requirements. An audit can apply to an entire organization or might be specific to a function, process, or production step. A system audit also delivers objective evidence concerning the need for the reduction, elimination and most importantly, prevention of...
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Cup of Joe 35# - Signing your electronic documents

Cup of Joe 35# - Signing your electronic documents

One of the main criteria for an eQMS is to have implemented an electronic signature. Many eQMS software have found many ways to handle this issue, but they all have to satisfy 21 CFR part 11. This part clearly paraphrases the fundamental rules of electronic signature implementation and control for compliance needs. When we are talking about...
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Cup of Joe 34# - How to organize your folders?

Cup of Joe 34# - How to organize your folders?

Most of the startups and small companies have a problem with organizing folders, especially if they are still using a paper-based QMS. Where is this file? Is it under review? Is this draft version? Is it approved? The need to check it and review it, then approve can take time and mistakes can be weird...
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Cup of Joe 32# - Good Customer Service Reduces Problems

Cup of Joe 32# - Good Customer Service Reduces Problems

Problems are always going to arise for any business no matter how hard you try to avoid them. While you can’t run a perfect business with all smooth situations, at qmsWrapper we can ensure friction doesn’t become an issue. You can always voice your challenges, we treat every issue as special, and not just another...
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Weekly Cup of Joe 31# - Move Your Budget into the Right Direction

Weekly Cup of Joe 31# - Move Your Budget into the Right Direction

There are countless benefits to implement a quality management system. We can all agree that an organization’s quality performance affects its bottom line. So, think of the investment in modern QMS software as an investment in preventing quality issues. The problem is with so many QMS software out there to choose from, how do you know which...
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Weekly Cup of Joe 30# – DHFs & CE Technicals with Traceability Matrix

Weekly Cup of Joe 30# – DHFs & CE Technicals with Traceability Matrix

An effective traceability process is essential requirements when developing medical device software and to achieving regulatory compliance. Traceability Matrix can be very difficult to create, it can take months to put together manually, especially without a proper tool. Creating and maintaining a TM can be time-consuming and difficult not to mention all those messy spreadsheets and ongoing...
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