Regulatory

Product liability issues can be costly to companies that aren’t prepared for them.

Medical devices regulation in the EU call for products to be monitored for their safety and not rely on complaints.

Medical IP’s software analyzes bone, muscle, fat, organs, and the central nervous system.

The two C-Path executives discuss how the organization works to translate new research into marketable treatments.

Culjat discusses how the FDA is considering regulations for certain types of mobile apps and software.

Representatives from regulatory authorities of the countries of Malaysia, Australia and South Korea discussed their respective challenges in the “International Drug-Device Combinations Session” at DIA Europe 2023.

New interactive tool, other resources help use regulatory strategy to drive successful business strategy for digital medical product development

Fiscal year 2024 budget includes improvements to medical device supply and shortage issues that negatively impact patients

COPD digital app can now be prescribed by medical providers in Germany and will be covered by statutory health insurance.

Trial will compare patients that undergo cardiac radioablation with Varian's CRA system vs. standard-of-care catheter ablation.

The joint pilot will test the use of a single eSTAR, an interactive form that guides applicants through the process of preparing FDA medical device submissions.

The hope is to build a formal framework for using digital health technology in clinical trials in Europe and beyond.

Benefits of business 4.0 approach in EDC in med-dev studies.

Shiri Diskin, PhD, Head of Medical Writing at Bioforum, sits down with Daphna Laifenfeld, PhD, Chief Scientific Officer at Ibex Medical Analytics to discuss the challenges associated with developing a CER and how to effectively navigate them while creating opportunities that increase efficiencies.