Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent ...
Artificial intelligence is moving quickly into mainstream medical devices, and the industry has become fluent in a familiar set of concerns: bias, transparency, and cybersecurity. These topics matter, ...
The next phase of digital mental health adoption depends less on innovation and more on how the industry uses real-world evidence, builds reimbursement frameworks, and applies regulatory precedent to ...
The EU MDCG 2025-10 Guidance on Post-Market Surveillance of Medical Devices and In Vitro Diagnostic Medical Devices (Dec 2025) provides manufacturers with detailed interpretations of MDR and IVDR PMS ...
How is software-enablement — connected devices and artificial intelligence — reshaping how products are conceived, developed, and deployed in clinical practice? Fragmented operations in large MedTech ...
The initial fear that the artificial intelligence and machine learning evolution will replace humans is shifting. A new narrative recognizes the potential for an AI-enabled workforce — one where the ...
The medical device industry faces growing pressure to align U.S. and EU regulations, with the EU’s Medical Device Regulation (MDR) and the FDA’s Quality Management System Regulation (QMSR) setting new ...
WALTHAM, Mass.–(BUSINESS WIRE)– Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced a definitive agreement to acquire Clario Holdings, Inc., a leading ...
Rejected by leading customers Physicians as customers/intermediary complicates adoption pathways. Emerges in niche/small markets Sophisticated epidemiology and real-world data allow larger initial ...
For over three decades, Sunrise Labs stood at the forefront of engineering excellence and medical innovation. Today, the company unveils its new identity: Suntra MedTech Solutions™, a bold evolution ...
Some manufacturers are now embedding CER processes within broader regulatory operating systems, integrating authoring, surveillance, and quality management to enable real-time adaptability. Artificial ...
A comprehensive update on the combination products market shows significant industry partnerships, development challenges, and strategic imperatives for success in the sector characterized by dynamic ...
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