USA – Device cybersecurity must be a priority from design through retirement, experts say
Cybersecurity must be a priority for any medical device that connects to the internet, from its earliest design phase to the end of its...
Europe – MDCG raises alarm over lack of MDR, IVDR applications
The European Commission’s Medical Device Coordination Group (MDCG) is telling medtech manufacturers to get certified under the new device and diagnostics regulations as soon...
USA – Combination products: Non-harmonized regulations are hurting manufacturers
Divergent global regulatory frameworks are making it tough for manufacturers to move ahead with innovative combination drug/device products, according to a panel of experts...
France – Conformité du marquage UDI : la norme ISO sur les Data Matrix...
Rappelons en préambule que pour procéder au contrôle de conformité d’un code Data Matrix, une ‘’douchette’’ ne suffit pas. On effectue ce contrôle au...
USA – TCET pathway may broaden access to breakthrough devices, but reforms still needed
While the Transitional Coverage for Emerging Technologies (TCET) pathway proposed by the Centers for Medicare and Medicaid Services (CMS) offers the potential to speed...
USA – Existing software development lifecycle tools can help speed AI/ML products to market
Software developers creating artificial intelligence/machine learning (AI/ML) medical products should move forward with the software development lifecycle (SDLC) models they are already familiar with...
USA – Providing context to AI/ML products may address explainability says FDA
Context is important when trying to address issues of transparency and explainability of artificial intelligence and machine learning products (AI/ML), according to a regulatory...
USA – Legacy devices report highlights need for data to support future policies
More data is needed to understand the risks legacy connected medical devices pose to the healthcare system, particularly in their vulnerability to cyberattack. That...
USA – FDA publishes final guidances on device shortage reporting, computational modeling
The US Food and Drug Administration (FDA) has published two final guidance documents for medical devices on the agency’s implementation of Section 506J of...
USA – Stakeholders not working together to develop AI standards, expert laments
Collective intelligence is necessary for the creation of standards for artificial intelligence.
That was the message Pat Baird, senior regulatory specialist at Philips brought to...
