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CHARLES BRADANOV

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Custom Templates according to your needs

Custom Templates according to your needs

You know those moments when you have software for handling the big things, but small processes end up taking an unreasonable amount of time and energy? That’s why qmsWrapper is always trying to take an innovative approach for better workflow. This time it comes out with a “Custom issue forms”! It will empower your team to...
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qmsWrapper’s growth on the market

qmsWrapper’s growth on the market

Research on the global medical QMS software market in 2020 describes the supply and demand situation, market landscape, and competitive scenario. The analysis is focused on the current trends done under the supervision of business specialists. The QMS market is starting to witness tremendous growth due to the increasing demand for effective management of organizational processes and...
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Premarket approval (PMA) or notification (510k)

Premarket approval (PMA) or notification (510k)

When someone is talking about pre-market approval or notification known as 510(k), they have in mind the US market. In the EU, the concept to get to the EU market is done differently. What you need to know to apply for approval or notification will be explained here below. For better understanding, you have to know...
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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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How to do an Offsite Audits

How to do an Offsite Audits

An offsite audit is the same as an on-site QMS audit, but the auditor engages with you via technology. The Initial Preparation  Prior to starting the offsite audit, most likely you, a medical device company, would need to provide copies of your quality manual, procedures, complaints, nonconformance, corrective and preventive action logs, etc. Also, you will have...
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Extraordinary circumstances require extraordinary measures-Offsite auditing

Extraordinary circumstances require extraordinary measures-Offsite auditing

Certain audits of medical devices and processes are essential for MedDev companies if they want to place their product on the European market. However, audits are not used only for those reasons. There are used for a variety of reasons, including assessing compliance with standards and regulations, adherence to requirements and specifications, evaluating process and system...
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Interview with one of qmsWrapper’s successful User

Interview with one of qmsWrapper’s successful User

qmsWrapper has many Users who have been renewing their license for several years now, showing how satisfied they are with this QMS software. qmsWrapper is intended for startups and small size companies engaged in the development of medical devices. The software is ideal for those who are switching from paper-based to eQMS without having experience with...
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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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qmsWrapper – Coronavirus (Covid-19) Statement

qmsWrapper – Coronavirus (Covid-19) Statement

One of qmsWrappers’s main priorities is Quality and Responsibility. As the situation with regards to the coronavirus (COVID-19) outbreak is evolving rapidly, we have made certain steps following the situation. Therefore qmsWrapper has taken into consideration the effects of the COVID-19 outbreak, we have analyzed our processes and we have implemented a contingency plan in...
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It's Your Own Data

It's Your Own Data

qmsWrapper believes in continuous growth, persistent improvement, and we are happy to announce the first major update/release for this year. First – qmsWrapper has a new feature that is helping you to be just one click away from securing your important data to your place! Why? Because your data is always your own, it’s your right...
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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. qmsWrapper’s core functionality was transformed from a tasks-based system to an enterprise-grade Processing Engine – to better support and enable your business workflows. Along with the Process Editor, business...
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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. In the medical device world, risk-based design and development is the new norm. For FDA clearance and CE Mark certification, ISO14971 is essential. And in May of 2020, the...
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A new Traceability Matrix so powerful, it becomes the products dashboard

A new Traceability Matrix so powerful, it becomes the products dashboard

TM is now more effective and useful feature that serves as a dashboard for product development leading to submission. You build your Traceability Matrix as you develop your product... Key functions of qmsWrapper Traceability Matrix: track and show the relationships and connections between requirements end to end traceability design controls, by column tracking number automatically assigned and inherited export into a print-ready...
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Jira is now “wrapped” with qmsWrapper

Jira is now “wrapped” with qmsWrapper

Now Medical Device startups and small businesses that use Jira can be connected to qmsWrapper. This integration will help medical device companies reduce their development risks and increase their agile effectiveness, whilst still keeping an eye on quality. “qmsWrapper got its name because it originally designed to ‘wrap’ Jira in a QMS blanket, to take advantage...
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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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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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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 the product or potential quality problems, 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...
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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? But...
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Ultimate Tips and Guidelines to Fine Tune Your Employee Trainings

Ultimate Tips and Guidelines to Fine Tune Your Employee Trainings

Tips and guidelines to create an efficient workforce and keep your business functioning at a high level. (ISO 90001, ISO13485, FDA510K)   Nobody wants to hire a person that is unable to do a job to a satisfactory standard. This is especially true when it comes to QMS related functions and activities. Besides, the candidate’s adequate competency...
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Validating or Not Validating for Intended Use?

Validating or Not Validating for Intended Use?

When I say Validation For Intended Use, most of you picture an extensive documentation required by ISO and FDA. Although Validation for intended use documentation is useful for several reasons (ensure accuracy, reliability, consistent intended performance, the ability to discern invalid or altered records, etc.) people mainly think of it as a regulatory requirement only. In FDA's...
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The Quality Manual F.A.Q. – Quality Manual Writing Tips

The Quality Manual F.A.Q. – Quality Manual Writing Tips

To pass a certification body audit, a Quality Management System must be an auditable entity with a neat Quality Manual. How to get useful ‘written stuff’? For hints on what to do, see the Quality manual writing tips part 2, in this short and clear infographic we collected 13 of the top F.A.Q.s and answers. If you want...
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