CHARLES BRADANOV

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...

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...

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...

As never before, during such technological opportunities and critical situations like this one, there is a necessity for such rapid reactions as it is now. If you are a medical device startup, or small business certainly you are holding your head that is filled with concern right now. You wonder how to minimalize the impact caused...

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...

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...

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...

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...

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...

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...

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...

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...

  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...

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, problems, or other unwanted situations.  It’s also a process that...

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...

The new version of qmsWrapper is updated in December 2019. We were still shaking from a disastrous ISO audit. Joe, the perennial QMS manager from Jurassic times, just have been fired. Even though he liked pushing the paper-based system, a medical device company has too many regulatory pitfalls to trip you up. Brilliant engineers and developers just...

Tips and guidelines to create an efficient workforce and keep your business functioning at a high level. (ISO 9001, 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...

The most important part of the manual is the description of the QMS The quality manual provides a wide range of benefits for organizations. Besides, that is easy to follow, it covers almost everything that company and its employees need to know about the ISO standards and what is expected of your quality management system. A bad...

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...

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...

In the previous article, we took a closer look at ISO13485:2016 and the pending doomsday scenario. In this article, I’ll take a closer look at the similarities between ISO 13485:2016 and FDA QSRs. Similarities between ISO 13485:2016 and FDA QSR A quick reality check of ISO 13485:2016, reveals that it actually looks more, smells more, and sounds...

  Document what you do and do what you document Quality Manual is the foundation and framework from where you build your organization. It is a plan, which sets the direction and navigates the organization within the defined parameters. Like any plan, it is good to revisit once in a while and check against the agreed objectives,...

In our fast-paced world, the risks we have to take and manage, in order to continue to grow and to develop, evolve quickly. Effectively managed risks help companies achieve their goals. Products that are developed following quality standards, have improved the quality of life for thousands of people. The idea of improving the quality of life...

  A checklist on where to start, and what to do first Whether you are freshly minted into the QMS position or you are a founder of a Medical Device Startup or a product manager with a new project, you’re reading this because your strategy requires QMS oversight and your first question is likely “where to start”...

Good QMS documentation is essential for an effective quality management system. Properly structured documentation will make your operations much easier, while incorrect documentation will bring you nothing but trouble. Use qmsWrapper to structure your QMS documentation, follow the necessary steps and avoid those unpleasant last-minute surprises.    What has to be included in a QMS Documentation, regarding ISO? Usually,...