Take Back Compliance
The Art of Managing Through Quality
Custom Templates according to your needs
Freshly made custom issue forms as a new driving force of your workflow, now build and design forms based on your business needs, your own self-designed templates all per requirements of the standard ISO 13485: 2016.
Meet qmsWrapper’s Project Manager and find out more about new features
How looks a working day for the qmsWrapper's Project manager? She is talking about her experience and much more, including a new announcement.
All that you need to know about Medical devices Class I
Main elements explained, all about Medical device class 1, from the EU (CE mark perspective) and the US (FDA) perspective including key differences and requirements.
The Wetling Company’s eQMS-journey
Read Success Story - how The Wetling Company stayed compliant thanks to their choice when it comes to eQMS. By offering the latest cloud-based eQMS solutions, qmsWarpper is their support in quality.
qmsWrapper’s growth on the market
Research on the global medical QMS software market in 2020 describes the supply and demand situation, market landscape, and competitive scenario. The analysis is focused on the current trends done under the supervision of business specialists.
Premarket approval (PMA) or notification (510k)
Basics that you should know when applying for premarket approval or 510(k). For each medical device explained including 'substantially equivalent’ devices and De Novo.
Post-market surveillance (PMS) of medical devices
As the medical device's complexity increases, post-market surveillance is getting more rigorous, so it can lead to earlier detection of potential failure at the end-user. To meet these needs, manufacturers should take a risk-based approach when considering clinical and medical device post-market surveillance requirements.
20 things you need to know about SOP for medical devices
SOP (Standard Operating Procedure) is required by the FDA, ISO, and other regulatory bodies. What SOP actually means? What are the 20 things you need to know about SOP?
20 facts about FDA Approval Process for medical devices
Every company that plans to sell its medical device on US ground has to register with the FDA. In the flowing list, you will find key points that will help you to be aware of what awaits you.
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.