MDSS and Covid-19

COVID-19 and Regulatory Affairs for MDR and IVDR Regulations

We at MDSS understand how Covid-19, in relation to medical devices and regulatory controls, and the Coronavirus pandemic brought new challenges, has reshaped the daily work life of those in the European Regulatory Affairs over the last year, and that the Covid-19 virus continues to do so.

Considering as well, the dynamic regulatory environment created by the recent Brexit, and the upcoming implementation of European Union Medical Device Regulation (MDR (EU) 2017/745) after May 26, MDSS has been and is working towards new solutions to provide worldwide manufacturers with the most suitable methods to be in Regulatory Compliance in good time. While the Covid-19 pandemic persists in changing global work habits, MDSS has been and continues to implement technological solutions to facilitate remote work for the growing number of employees.

Measures taken by MDSS are not limited to remote work. To provide protections against Covid-19 pandemic in the workplace, MDSS constantly provides supplies such as face masks, disinfectants, and transparent shields between workstations. Further, MDSS makes self-tests available for the in-house employees at regular intervals as part of this safety program.

Dealing with Covid-19 has fueled MDSS to work with our clients and help bring about extraordinary measures in the MD, IVDD Regulatory and compliance fields.

MDSS considers it vital to provide support for clients with the registration and special approval processes.

MDSS is always available when and where you need us.

Ludger Moller, President.