Blog

Canada has been facing the same difficulties as many other nations due to the novel coronavirus. In light of the shortage of medical equipment and the PPEs, Health Canada relaxed their policies to let medical equipment and other necessary supplies...

Amid the pandemic situation, and states’ officials struggling to secure Personal Protective Equipment, FDA released a guidance document that relaxes the regulations surrounding the manufacture of PPEs. The guidance is intended to stay in effect only until the end of...

On Tuesday, March 31, 2020, the FDA announced a new program aimed at facilitating research and development of COVID-19 treatments. With over 920,000 confirmed cases globally, the Coronavirus pandemic is forcing the FDA to create a rapid pathway for treatments.1...

The European Medical Device Coordination Group published a joint implementation plan ahead of the May 2020 deadline for the full implementation of the EU MDR. The plan addresses the concern that the implementation of the MDR has proven to be...

With the number of confirmed COVID-19 cases now exceeding 200,000 globally, the WHO and many other international government agencies are either recommending or enforcing a “shelter in place” order to slow the spread of the disease.1 This is an unprecedented time...

With the COVID-19 pandemic halting life as many know it globally, the May 26th EU MDR deadline still looms over the medical device industry. Many industry groups and notified bodies have called upon the Commission to postpone the deadline until...

Earlier this month the ECRI Institute published its executive brief on this year’s Top 10 Patient Safety Concerns. The ECRI (formerly the Emergency Care Research Institute) is an independent nonprofit organization that focuses on conducting independent medical device evaluations to...

Amid the COVID 19 pandemic, with 10 states in the US declaring a ‘state of emergency’, foreign and international travel restrictions, FDA released a series of advisories and statements to keep the public informed of the situation. The FDA is...