qmsWrapper Blog

Verifying the effectiveness of corrective and preventive actions (CAPAs) closes the loop between identifying a problem and completing the actions to solve it.

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 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.

Read about how Medical device startup "Cardio-Phoenix" successfully carried out the audit with help of qmsWrapper.

It’s a cloud-based development and compliance management software, in layman’s terms, a QMS and Project management system specifically designed for medical device companies, including start-ups.

The Traceability Matrix in qmsWrapper™ is fully integrated into the project and quality management. Map and Trace the design control relationships for your medical device.

This article includes what is a QM, and what should include, Common mistakes & how to avoid them, Pro tips & best practices on how to do it right ...

By equipping employees with the tools and knowledge to perform their jobs, you can expect better performance and a more cohesive workplace.

The quality manual covers almost everything that company and its employees need to know about the ISO standards and what is expected of your quality management system.

Learn more about pitfalls, what you should do and benefits of establishing the Validation for Intended Use Documentation

Tips and answers on how to effectively write Quality Manual for your company

A quick reality check of ISO 13485:2016, reveals that it actually looks more, smells more and sounds more, like FDA’s QSR.

Quality Manual is the foundation and framework from where you build your organisation. It is a plan, which sets the direction and navigates within the defined parameters.

This is a real and topical question. At every MedDev or MedTec oriented exhibition this is the off-stage topic, actually more like main grippe session.

The following infographic will help you recognize the primary causes and warning signs for potential data loss and the top tips for prevention.

Risk management is one of the key factors in quality management. Effectively managed risks help companies achieve their goals.

In this infographic, we present the actual percentages of the improvements your company can achieve with a cloud-based QMS or Project management software.

The advantages to such integrated QMS systems is that ISO compliance is not limited to “reporting” or the tracking of reports to prove the quality, but rather is integrated into your workflow processes directly, so quality becomes everyone’s business throughout the workday.

QMS approval processes are supporting the accurate recording of acceptance or agreement in business documents.

Every given task needs to have a clear priority. In the medical device industry, when everything seems so important it is a must to ...

The QMS documentation can be impenetrable. How to outsmart the system? In many cases a simple document management system won’t even do the expected job.

Good time management requires driving attention from activities to results: being busy isn’t the same as being effective.

The Quality Manual requires many references to the applied company and the workflow processes. Synchronously, most quality management related references are advising to ...

Good QMS documentation is essential for an effective quality management system. Properly structured documentation will make your operations much easier.

QMS and PM software are usually put together from series of APIs, they are disjointed and all together operate like Dr Frankenstein’s creation.