Interview with one of qmsWrapper’s successful User
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.
Best Medical Device startups based on AI in 2020
Artificial intelligence (AI) research within medicine is growing rapidly. New technologies are keep growing along with new discoveries, so do the medical device startups.
Top 10 MedDev conferences and summits to attend this year 2020
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 European Commission proposed MDR delay
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.
Cup of Joe #48 – qmsWrapper: messaging from home
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.
NEW MDR: May 2020 postponed
According to the latest EC news, the MDR deadline may have been postponed. As a result of the disruptions caused by COVID-19.
10+ essential things what MedDev startups must know
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.
An effect of COVID-19 on upcoming quality and regulatory interactions
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.
Coronavirus Measures: How qmsWrapper feature helps you stay at "work" from home
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.
Medical Device Trade Shows after COVID-19
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.
qmsWrapper – Coronavirus (Covid-19) Statement
Quality Management System (QMS) Software qmsWrapper statement policy on Coronavirus COVID-19.
It's Your Own Data
qmsWrapper has a new feature that is helping you to be just one click away from securing your important data to your place!
Cup of Joe #47 - 2 Risk Modules
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.
Enterprise-grade Processing Engine
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 New Risk Module supports risk-based design
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.
The Ultimate Content List of Technical File for CE marking
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.
8 things to know about CE approval process for Medical Devices
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 things you must know about CE Mark
5 Answers on Most Important Things You Should Know About CE Mark.
A new Traceability Matrix so powerful, it becomes the products dashboard
qmsWrappers Traceability Matrix clearly demonstrates to inspectors/auditors the connection between the requirements, its design inputs, validation and verification, risk analysis, etc.
Jira is now “wrapped” with qmsWrapper
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.
Cup of Joe #46 - New superpower for MedDev through qmsWrappers TM
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.
Wrap Jira in QMS
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.
Top 10 medical device trade shows 2020 not to be missed
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.
Cup of Joe #45 - How to choose a good manufacturer?
It’s not an easy task to find a good outsourced manufacturer for your needs, for your medical device that should conquer the market.