qmsWrapper Blog

The Traceability Matrix in qmsWrapper™ is fully integrated into the project and quality management.

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.

Improve Customer Retention and Ensure That You Keep the Finger on the Pulse. Joe will guide you through ISO compliance

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 ...

Smart companies invest in the development of their employees. QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.

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

Without specific parameters or with the wrong requirements, you might end up approving things that might turn out to be quite different from what you expected.

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

Integrated PM and QM includes features such as QMS approval workflows, document history management, scheduling meetings, etc.

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.

Documenting improvements are more important that the ideas itself because an idea that is not documented, does not exist.

qmsWrapper will secure cloud Quality& Project Management System solution to ensure up-time, diminish data loss, & maximise productivity ...

Ignoring preventive actions might sound like saving money at first, but not investing resources into improving processes will cost more on a long term.

Your risk controls will have a direct impact on your design outputs. An inappropriate risk management strategy will lead to incorrect hazard evaluation.

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

Company policies should include and cover managing, identifying and updating all the documents that contain references to obsolete versions or documents.

If your company would like to achieve ISO 13485 certification,provide a clear picture of the organisations context to the auditors.

If you do QMS right, it’s not a burden, not an added layer of management that gets in the way. The following checklist will guide you.