We are using cookies in order to offer you the most relevant information. We have published
new Cookie Policy which you should read to find out more. more.
Please accept cookies for optimal performance.

Showing posts tagged with: coronavirus

It’s Official – MDR was postponed for a year

It’s Official – MDR was postponed for a year

The European Parliament voted to suspend the implementation of the MDR by one year. The decision to delay took into account the challenges of the coronavirus pandemic and the need for increased availability of vitally important medical devices across the EU while continuing to ensure patient health and safety until the new legislation becomes applicable.   On 25...
Keep reading
The European Commission proposed MDR delay

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. The European Commission has faced increasing pressure to implement a delay as the novel coronavirus has taken hold of Europe and much of the...
Keep reading
Cup of Joe #48 – qmsWrapper: messaging from home

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. qmsWrapper does not see any issue when it comes to working from home. We are cloud-based QMS software, and it’s made to support continued team connection and business flow. It also...
Keep reading
NEW MDR: May 2020 postponed

NEW MDR: May 2020 postponed

qmsWrapper has already written about the New EU Medical Device Regulation (MDR), and what you can expect when it comes into effect. Everyone is aware that all Medical Device companies that sell medical products in Europe must hold up to the new regulation. Companies that do not follow this regulation will not be allowed to...
Keep reading
An effect of COVID-19 on upcoming  quality and regulatory interactions

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. Potential delays in regulatory communication and meetings will continue for months. 'Stay At Home' measures and the very limited allowable travel, with no...
Keep reading
Keep reading