qmsWrapper Blog

qmsWrapper has become the right choice for Jira users who need Quality Management System.

Medical device manufacturers will enjoy Multiuser TM which brings a valuable couple of benefits: save time, help you work faster, it's more effective.

qmsWrapper announces 4 major upgrades: Traceability Matrix, Risk Module, Process Engine, and integration with Jira.

Tradeshows are an excellent opportunity for exhibiting the newest products and any kind of innovation that your company has made. Check the top 10.

It’s not an easy task to find a good outsourced manufacturer for your needs, for your medical device that should conquer the market.

The New regulation (MDR 2020) is knocking on a door to Medical Device manufacturers. Transition time is running out, it’s just 6 months away.

When someone owns a medical device company, but not having a space or supplies for producing equipment, then they hire a contractor, outsourced manufacturer.

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

Root cause analysis is basically a process with a systematic approach for identifying a problem

Root Cause Analysis is something that we all do when we want to solve a problem for good. But what RCA actually means?

Failure to stick to proper corrective and preventive actions is considered a violation of regulations on good manufacturing practices.

When implementing and maintaining ISO standards such as ISO 13485, it is burdensome to maintain paper-based documentation and it’s very time-consuming.

Besides its compulsory requirement, CAPA helps companies to enhance their quality system to reduce risks and avoid potential problems in the future.

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

It's one thing to become ISO certified, but maintaining the certification is another thing with all the updates and new records.

A successful audit relies on communication. The most important step is the preparation of employees for how to interact with the auditors.

How to overcome the auditor's visit that always generates tension and anxiety? Track our guide.

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.