qmsWrapper Blog

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.

How looks a working day for the qmsWrapper's Project manager? She is talking about her experience and much more, including a new announcement.

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.

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.

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.

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.

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.

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?

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.

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.