qmsWrapper Blog

The Medical Device life cycle is considered a development of the product, from the very beginning to the end. What is the beginning, what is involved in the middle, and what is considered the end will be explained in this article.

An offsite audit is the same as an on-site QMS audit, but the auditor engages with you via technology.

Certain audits of medical devices and processes are essential for MedDev companies if they want to place their product on the European market. Audits are not used only for those reasons.

With the ever-changing global marketplace of today, medical device companies are feeling the pressure of competition, the pressure to provide the most value and highest quality in their medical products.

The European Parliament voted to suspend the implementation of the MDR by one year because of the coronavirus pandemic. This decision has been made.

We can’t emphasize enough how important is to understand the language of medical devices. To meet the requirements and the Regulations it’s essential to understand what is meant by keywords and phrases.

A QMS manager safeguards that standards are met throughout all processes of the company, from customer relations to manufacturing processes and all in between.

qmsWrapper team was interviewing one of our Users who become qmsWrapper Consultant – Emma Fortin. Read what she had to say about software and collaboration with the Support team.

Artificial intelligence (AI) research within medicine is growing rapidly. New technologies are keep growing along with new discoveries, so do the medical device startups.

There are many reasons to attend a conference. Regardless of the current COVID-19 outbreak, this does not mean that you shouldn’t plan the next step for growing your business.

The Medical Device Regulation (MDR) was due to become fully applicable on 26 May 2020. However, the outbreak of COVID-19 has placed unexpected pressures on economic operators, notified bodies and competent authorities.

The Coronavirus (COVID-19) outbreak is creating a massive challenge for many businesses. Millions of people are taking refuge from the coronavirus by working at home.

According to the latest EC news, the MDR deadline may have been postponed. As a result of the disruptions caused by COVID-19.

It is not easy to build a Medical Device. And we all know that every beginning is hard. Therefore, for startups, it’s quite a challenge. But fear not. More you know, easier it is.

COVID-19 is now in full swing. Its spread is felt through pressure on world healthcare organizations. Nonetheless, no delay in the regulatory approval of medical device products has been observed so far.

If you are a medical device startup, or small business, you probably wonder how to make your company suffer as less possible from this impact and trying to figure out how not to affect the success of your business and still remain compliant.

Based on the trending situation of Coronavirus (COVID-19) and the time when the pandemic is predicted to last, Medical Trade Shows are postponed. We will help you be updated: new dates are available.

Quality Management System (QMS) Software qmsWrapper statement policy on Coronavirus COVID-19.

qmsWrapper has a new feature that is helping you to be just one click away from securing your important data to your place!

A new Risk Analysis Module (RAM), is introduced to help focus on the relationship between requirements, design, and benefits, with emphasis on risk-based design.

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.

Risk Analysis Module becomes a very important update, next to other features: Traceability Matrix, Process Engine, and Jira integration. 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.

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.