qmsWrapper Blog

Massive update of the year is happening and qmsWrapper’s Users will be thrilled to find out what is new in one of the 4 upgrades – Process Engine.

The Risk Analysis Module becomes a very important update. Changes will make Risk Assessment much easier and clearer.

Some general details of the kind of information which will be required in the Technical File. As a general guide, the following items should be included.

Determination EU Medical Device Directive which applies, Device Classification, Implementation of QMS, Technical File Preparation, etc.

5 Answers on Most Important Things You Should Know About CE Mark.

qmsWrappers Traceability Matrix clearly demonstrates to auditors the connection between the requirements, its design inputs, validation and verification, etc.

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.