qmsWrapper Blog
Take Back Compliance
The Art of Managing Through Quality
20 facts about FDA Approval Process for medical devices
It is not easy for medical device manufacturers to face that torrent of information that awaits them when they need to face regulatory bodies and launch their device on the market.
Every company that plans to sell its medical device on US ground has to register with the FDA. In the following listing you will read...
What is medical devices lifecycle
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.
How to do an Offsite Audits
An offsite audit is the same as an on-site QMS audit, but the auditor engages with you via technology.
Extraordinary circumstances require extraordinary measures-Offsite auditing
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.
Cup of Joe #49 – Do You Need A Consultant?
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.
It’s Official – MDR was postponed for a year
The European Parliament voted to suspend the implementation of the MDR by one year because of the coronavirus pandemic. This decision has been made.
Basic Terms in Medical Device Industry
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.
QMS Manager role in MedDev industry
A QMS manager safeguards that standards are met throughout all processes of the company, from customer relations to manufacturing processes and all in between.
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).
