Home     |     Our Team     |     News     |     Contact Us     |     Call: 508-231-8842

The Latest Updates to FDA’s COVID EUA’s

The Latest Updates to FDA’s COVID EUA’s

The COVID-19 pandemic has made obscure regulatory procedures big news across the globe. Chief among these is the Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) authority, the expedited pathway through which COVID-19 vaccines were authorized....

Artificial Intelligence and Medical Devices

Artificial Intelligence and Medical Devices

Growing numbers of medical devices are using artificial intelligence and its associated technology—machine learning—to diagnose patients more precisely and treat them more effectively. Although many devices have already been cleared by the FDA, many regulatory...

MDR Transition: What does it mean for your company?

MDR Transition: What does it mean for your company?

Talk about the fundamental changes coming to European medical device regulation has been buzzing through the industry for the past several years. Medical device firms across the globe have been preparing themselves for changes to their regulatory compliance strategies...

How the Pandemic Affects MDSAP Audits

The Medical Device Single Audit Program (MDSAP) has been a blessing for many medical device manufacturers because it has allowed third-party auditors to conduct a single audit of a medical device company to satisfy the regulatory requirements of the five countries...

In Vitro Diagnostic Regulation Update

In Vitro Diagnostic Regulation Update

In less than 430 days, the In Vitro Diagnostic Regulation will fully replace the EU’s current Directive on in vitro diagnostic medical devices (IVDD 98/79/EC). Are you prepared for the transition? What is In Vitro Diagnostic Regulation (IVDR)? The IVDR is the new...

Eudamed Update: Implementation is Paused, MDR Compliance is Not

Notified Body Audits during the Pandemic: New MDCG Guidance

It should come as no surprise that the far-reaching effects of the COVID-19 pandemic include how notified bodies are conducting audits of medical device manufacturers. The European Commission’s Medical Device Coordination Group (MDCG) recently released a document...