qmsWrapper Blog

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.

COVID 19 has hit the whole planet, including businesses. Medical companies must be wondering how to stay ISO-compliant in this situation.

Based on the COVID-19 situation and the time when the pandemic is predicted to last, Medical Trade Shows are postponed. New dates are available.

Quality Management System (QMS) Software qmsWrapper statement policy on Coronavirus COVID-19.

qmsWrapper has a new feature that is helping you to be just one click away from securing your important data to your place!

A new Risk Analysis Module is introduced to help focus on the relationship between requirements, design, and benefits, with an emphasis on risk-based design.

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 Risk Analysis Module becomes a very important update. Changes will make Risk Assessment much easier and clearer.

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.

Determination EU Medical Device Directive which applies, Device Classification, Implementation of QMS, Technical File Preparation, etc.