Showing posts tagged with: COVID-19
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...
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...
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...
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...
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...
Coronavirus Measures: How qmsWrapper feature helps you stay at "work" from home
As never before, during such technological opportunities and critical situations like this one, there is a necessity for such rapid reactions as it is now.
If you are a medical device startup, or small business certainly you are holding your head that is filled with concern right now. You wonder how to minimalize the impact caused...