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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.

As a medical device manufacturer which wants to place its product on the European market, you must be aware of all requirements to do so. Of course, one of the first things, you need to comply with Europe’s Medical Device Regulation (MDR).

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

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

The combination of JIRA brings a system in which Medical Device Startups are able to track, manage and organise all CE Technical Files and FDA Design History Files, and do it in the most effective manner possible.

News in qmsWrapper are Integration with Jira Software, updated Risk Module, and Process Engine and, best for the last - upgraded Traceability Matrix! Joe will introduce you to the first one of the super upgraded Traceability Matrix.

qmsWrapper announces 4 major upgrades. Our new Traceability Matrix as the new dashboard, and with Jira software integration,..., no struggle with FDA and Ce Mark submission.

Tradeshows are an excellent opportunity for exhibiting the newest products and any kind of innovation that your company has made. It’s perfect for brand awareness, as well, as for promoting your business.

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?

During the audit process, CAPA is always in the center of attention, and auditors are very strict when it comes to it. Also, failure to stick to proper corrective and preventive actions is considered a violation of regulations on good manufacturing practices.

When implementing and maintain ISO standard such as ISO 13485, it is burdensome to maintain paper-based documentation and it’s very time-consuming. It is quite a struggle to find information when needed in the thick of ‘forest’ of document history.

The purpose of corrective and preventive action is to collect and inspect information, identify and examine product or potential quality problem, then take suitable and effective corrective/preventive action.

Every company has as part of its organization set of procedures and processes. The purpose of having procedures is to drive efficiencies towards fewer errors and resulting reworks, which can improve cost saving. Besides that, their purpose is also to make sure 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. So, preparation of employees in order to know exactly how to interact with the auditors when they arrive is one of the most important steps.

An audit is verification of activities – process or quality system in order to ensure compliance to some requirements. As such audits always generate tension and anxiety – because you know that some stranger is coming to check your work and could give you a failing grade!

At work, nothing raises the hairs on the back of your neck like the word “audit”. Audits mean fault, mistake, short-coming and blame, fault, culpability all wrapped in disappointment – you have failed! The bullies incorporate love them! But the wise manager embraced them and uses them to pre-empt the bullies, by self-auditing.

An Audit is the on-site verification activity of a process or quality system, to ensure compliance to requirements. An audit can apply to an entire organization or might be specific to a function, process, or production step.

One of the main criteria for an eQMS is to have implemented an electronic signature. Many eQMS software have found many ways to handle this issue, but they all have to satisfy 21 CFR part 11. This part clearly paraphrases the fundamental rules of electronic signature implementation and control for compliance needs.

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