qmsWrapper Blog

What are 5 the most frequently asked questions about ISO 13485? Check the questions, but find out all answers.

Create your own forms to collect data and generate quick reports from it. Free templates are available, so you can customize them to suit your needs.

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

The main elements explained, all about Medical device class 1, from the EU and the US perspective including key differences and requirements.

Read Success Story - how The Wetling Company stayed compliant thanks to their choice when it comes to eQMS.

Research on the global medical QMS software market in 2020 describes the supply and demand situation. qmsWrapper plays a big role, find out why.

Basics that you should know when applying for premarket approval or 510(k). For each meddev explained including 'substantially equivalent’ devices and De Novo.

As MedDev's complexity increases, post-market surveillance is getting more rigorous, so it can lead to earlier detection of potential failure at the end-user.

Standard Operating Procedures are required by the FDA, ISO, and other regulatory bodies. What are the 20 things you need to know about SOP?

Every company that plans to sell its meddev on US grounds has to register with the FDA. In the list, you will find key points of what awaits you.

What is the beginning of the medical device lifecycle, what is involved in the middle, and what is considered the end?

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

Certain audits of meddev and processes are essential for companies if they want to place their product on the European market.

When is the right time to hire a consultant? Do you need it and why?

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

To meet the requirements and the Regulations it’s essential to understand what is meant by keywords and phrases in the medical device 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 the qmsWrapper Consultants – Emma Fortin. Read what she had to say about software and collaboration with the Support team.

Artificial intelligence research within medicine is growing rapidly. New technologies keep growing along with new discoveries, and so do meddev startups.

Attending conferences? 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 was due to become fully applicable on 26 May 2020, but COVID-19 has affected this matter as well.

The 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 MedDev, and we all know that every beginning is hard. For startups, it’s quite a challenge. The more you know, the easier it is.

The spread of COVID-19 is being felt through the pressure on the WHO. Nevertheless, no delay in regulatory approval of meddev products has been observed so far.