News and Resources
Speaker Program Fraud: What You Need to Know to Protect Yourself
The healthcare industry can be full of tempting offers, many perfectly legal, though there are some that are not. To make matters more difficult, illegal ones can appear above-board and acceptable when, in fact, some aspects of them pose a significant legal risk to...
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?
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...
Eudamed Update: Implementation is Paused, MDR Compliance is Not
The new European medical device database, known as Eudamed, was originally scheduled to launch in May 2020, but the pandemic caused its implementation to be delayed two years, until May 26, 2022. However, that does not mean that compliance considerations are on hold. ...
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 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...
Risk Management Series – Article 7 Part A: Determining Risk Acceptability
In our last two articles, Part 5: Assigning Harms and Severity and Part 6: Estimating Probability of Occurrence, we discussed approaches to develop values for these two elements of risk and the challenge of completing these...
Telemedicine: How the pandemic has changed healthcare services
While telehealth technology and its use are not new, trends show some increased interest in the use of telehealth services by both healthcare professionals (HCP) and patients. Due to the COVID-19 pandemic, changes in the way that healthcare is delivered are being...
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...
Securing Updated and Necessary Statutory Evaluations Timely Rule
In the Trump Administration’s final days, the Department of Health and Human Services (HHS) has changed the US Food and Drug Administration’s (FDA) regulatory oversight policies. The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule would force...
