qmsWrapper Blog

At work, nothing raises the hairs on the back of your neck like the word “audit”. Find out why it is that much important.

Audits are carried out in order to confirm that the individual elements within the system are effective and suitable for achieving the stated objectives.

One of the main criteria for an eQMS is to have implemented an electronic signature. Why? How?

Most of the startups and small companies have a problem with organizing folders, especially if they are still using a paper-based QMS.

One of the main fears when transferring from paper-based to eQMS is how to handle a lot of file versions, how should we name them, etc.

While you can’t run a perfect business with all smooth situations, at qmsWrapper we can ensure friction doesn’t become an issue.

There are countless benefits to implementing a QMS. Think of the investment in modern QMS software as an investment in preventing quality issues.

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

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.