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Medical Device

IVDs – A Comparison of Requirements between the US and EU

Get insights on the differences and similarities in IVD requirements between the US and EU markets.

Medical Device

A Comparison Between IVDR and MDR Software

Learn about the qualification process, classification rules, and standards that apply. Stay compliant with medical device regulations.

Medical Device

Clinical trials involving Medical Devices and Medicinal Products. How can we manage regulatory assessments?

Learn how to manage regulatory assessments for clinical trials for medical devices and medicinal products. Understand different scenarios and.

Medical Device

New FDA guidance on premarket submission for software: what happens now?

New FDA's guidance providing updates on the documentation recommended for inclusion in premarket submissions for its review of device software.

Medical Device

Medical Device Regulations in the EU (MDR) vs. FDA (US Food and Drug Administration)

Challenges and Considerations in Launching a Medical Device in Multiple Markets. A comparison between EU (MDR) vs. FDA (US Food and Drug.

Medical Device

How to Find Your Way Through the New Regulatory Changes for Medical Devices: A Comparison of Old vs. New

The new European changes in the medical device regulatory scope, and the particular characteristics of the Polish law.

Medical Device

New Trends in Guidelines for Continuous Process Manufacturing

The importance of Continuous Manufacturing (CM) and its different approaches. The new guidelines and trends of continuous manufacturing explained.

Medical Device

New Extension on the Regulation of MD and IVD Transition Periods

The European Commission proposed to extend the certification period for medical device suppliers by 4 years to avoid shortages. Are you compliant?

Medical Device

Clinical Trials Involving Medical Devices and Medicinal Products

How can we best manage regulatory assessments? Here is three explanatory cases related to medicinal product clinical trials involving medical devices.

Medical Device

FDA Software Guidance; Should I be worried?

FDA released a draft guidance: Computer Software Assurance for Production and Quality System Software. What changes could it bring?