CHARLES BRADANOV

We're thrilled to announce the latest release of qmsWrapper, packed with new features and improvements. In this release, we've focused on three key areas that are essential for your work: Forms, Risk, Streamlined Processes, and much more.  Let's delve into the exciting updates:   All about Meetings! Meetings play a crucial role in ensuring compliance with regulatory requirements, and...

We are excited to share that qmsWrapper earned five G2 badges for the winter. People have spoken, and qmsWrapper has been recognized in a number of categories thanks to their encouraging comments. Discover the main factors contributing to qmsWrapper's success, read user reviews, and discover which features users prefer best. Category: Medical QMS "High Performer Europe" Category:...

qmsWrapper's Document Management application, the WrapperApp, has undergone a comprehensive background coding update, enhancing its power and extending accessibility beyond Windows users to include Mac and Linux users.   Unlock the Potential of WrapperApp WrapperApp empowers users with a wide array of features designed to simplify document management and boost productivity. Here's a glimpse of what you can...

Even amidst the summer season, the dedicated qmsWrapper team continues to work tirelessly on enhancing the software, as expected. The latest version boasts two significant changes, with one of them poised to greatly assist Quality Managers in efficiently organizing their QMS documentation.   Document Management: Folder Structure The introduction of an advanced Document Management functionality within qmsWrapper's Storage...

Our dedication at qmsWrapper to developing better software is unshakable. We appreciate customer input and work to make our quality management software more functional. We are pleased to announce the release of two significant upgrades that will improve user roles within qmsWrapper and significantly streamline document approval information access.   Introducing QR Code for Approved Documents: The adding...

Software for quality management systems (QMS), qmsWrapper, is pleased to announce that it has recently earned two prestigious badges from G2 for the Summer 2023 season. Because of its dedication to client satisfaction and distinctive collection of features, qmsWrapper stands out in the market.   qmsWrapper's Badge: High Performer Europe - Summer 2023 One of the honors qmsWrapper...

Canada, May 22, 2023 - This comprehensive release introduces several key enhancements, including added process templates that are further supporting the Medical Device Regulation (MDR) and strengthened security measures. With these advancements, qmsWrapper is dedicated to helping medical device manufacturers navigate the complexities of changes from MDD to MDR compliance that has to be properly...

We at qmsWrapper are pleased to report that, as a result of the enthusiastic comments and support from our customers, we have obtained four badges on the G2 website. These certificates prove our team's commitment and effort in producing the most effective Quality Management System software imaginable.     First, the Europe Regional Grid Report awarded us the...

There is still a little time left until the end of 2022, so it is the right time to sum it up and set new goals for 2023. The qmsWrapper team has been working on the development of the software and brought many updates to old and new users. We had difficulty finding a solution for...

Autumn has arrived and with it another recognition from our clients, which they expressed through the G2 portal. This year contained a lot of upgrades and special customization to fully support our client's needs and equip the qmsWrapper family with the latest QMS features. The good work is now rewarded with another recognition from one of...

Our software continues with excellent results this year. Spring brought us the first recognition from G2, one of the leading portals for finding the perfect software for your business, and we continue at the same pace this summer. Officially, qmsWrapper gets the badge "High Performer for Summer 2022" in the category Medical QMS Software.   In the previous period,...

Audit day, the feared day. But does it have to be that way? Imagine a situation where your auditor is amused because you have prepared all the necessary documentation that has to be presented, all in excellent order, accessible through excellent software. Organize yourself in time, and your documentation… Some documents are certainly valid from the...

Change can be daunting, but sometimes change just makes sense. qmsWrapper has developed a better way to access QMS functionality in qmsWrapper. It’s a new UI or Dashboard, and QMS Control Tables. Fear not, the essential underlying function remains unchanged. How you access the data does. The new dashboard puts more QMS functionality at your users' fingertips. First, we introduced Tabs...

Have you received a document that needs your approval? If you did, do you know when? How do you know if it is urgent? The advantage of QMS software is the efficiency on a higher level compared to a paper-based QMS. With eQMS all documents can be created in a short time, easily sent for approval, get...

Maybe it’s doesn’t make a big difference, but it does actually! Based also on many requests of our clients, here it is.   qmsWrapper File App The Wrapper File App was developed to make file/document editing easier and safer. It saves time and makes your job much simpler. With this app, at least two redundant steps are taken...

Preparation of the QMS documentation is based on the organizational needs, and it is crucial for an efficient QMS. Besides, correctly organized documentation will make operations much easier.   The purpose of QMS documentation is to provide a clear framework for the company’s operations and a better understanding of the QMS, and finally to show the evidence...

A remote audit, also known as virtual audit, is the method of conducting an audit distantly, using electronic means such as videoconferencing, email, and telephone to acquire audit evidence, just like during an on-site audit.  The overall aim is to evaluate this evidence objectively to determine the extent to which we have fulfilled the audit criteria. The...

Remote audits may have many benefits when it comes to efficiency, access to competence, increased reach and mitigating risks. But companies have to use it in the right context. The main benefit of remote auditing is cost flexibility. Auditors will incur fewer costs through every remote audit they conduct, such as travel expenses and billable hours....

Audits are used for a variety of reasons, including assessing compliance with standards and regulations, adherence to requirements and specifications, evaluating process and system performance, evaluating the adequacy and effectiveness of the quality management system; etc. A remote internal audit is usually done partially or completely off-site employing technology to support the auditor when a site...

Over the last few years, it’s a noticeable progressive growth in the global market in the adoption of software for quality management systems. The automation of the Quality Management System significantly eases the potential risks and operational costs of conformance to regulatory requirements in any sector or industry type. The need for effective management of...

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...

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...

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...

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...

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...