Impact of COVID-19 to Technology and delayed MDR
Technology might be one of the areas that are under the impact, but not directly impacted by COVID-19.
Even though many QMS software is now cloud-based, most medical device startups are not prepared for a complete switch from in-office presence to remote work.
It is important to ensure that the following are available to all employees:
- hardware (laptops, monitors, and peripherals)
- access points (licenses, seats, and VPN connections)
- support (user guides, FAQ, and troubleshooting guides)
Video conferencing capabilities should be available for all employees. It aims to support continued team connection and business continuity, as well as real-time interactive communication to aid in the remote work transition.
Now, more than ever, medical device companies are thinking about moving to cloud-based systems and applications, but we know this is a longer-term investment. Companies employ very intense network monitoring programs and testing procedures to try to improve connectivity issues.
With a heavy reliance upon remote access and a distributed workforce, information security practices and protocols are now being tested more than ever.
It will be surprisingly easy for staff, especially those new ones who are starting to work remotely, to download and store sensitive information on relatively insecure home networks and devices. Therefore, it is very significant to continue to stress information security policies and procedures for employees during this time.
Business continuity plans must be put in place on how to operate when systems are down. If they aren’t already. Disaster recovery plans and redundant systems should be tested to guarantee they are working correctly. Continuity and emergency plans may soon be tested as different countries, states, and cities enact quarantines or other restrictions on the free movement of people.
In addition to the impact that the coronavirus has on technology, it also influences the placing into force new laws that are inevitably delayed in this case.
Such as New MDR 2020 – As COVID-19 continues to intrude Europe and pull medical device companies in different directions, European Commission announced that the commission will propose to delay the implementation of the Medical Devices Regulation (MDR) by one year.