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 must have a set of procedures and processes to ensure that they are in compliance with regulations.

We scoured the web for high-quality conferences in 2019 and made a list that every medical device manufacturer must attend.

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 PM system specifically designed for meddev companies.

The Traceability Matrix in qmsWrapper is fully integrated into the project and quality mngt. Map and Trace the design control relationships for your meddev.

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 the company and its employees need to know about the ISO standards and what is expected of your QMS.

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 most effective QMS system takes a more inclusive approach to business processes, combining ISO compliance with teamwork, workflows, doc. and project mngt.

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.

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.