FDA's new medical device quality management rules align U.S. standards with global requirements and give inspectors new ...
Medical device association AdvaMed has hired Melissa Torres to replace Janet Trunzo as EVP of technology and regulatory affairs.
On 20 January 2026, Ropes & Gray’s Global Life Sciences Regulatory & Compliance team hosted the “Life Sciences Regulatory Outlook 2026” webinar.
Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision ...
Cambridge, UK - Regulatory compliance in medical device development is often treated as a hurdle to be cleared late in a programme. In practice, addressing it too late can introduce significant ...
The "Medical Device Regulatory Affairs Market Size, Share & Trends Analysis Report By Type, By Service Provider, By Service, By Region, And Segment Forecasts, 2025 - 2030" report has been added to ...
The advent of artificial intelligence (AI) and data-driven methodologies has triggered a wave of transformation in regulatory compliance and quality assurance for the development of medical devices.
Etienne Nichols, a medical device guru and community manager at Greenlight Guru, recently posed an interesting question to his LinkedIn network: If you were in charge, what regulation would you change ...
January 13, 2026 - PRESSADVANTAGE - In the highly regulated field of medical device labeling translation, ensuring that ...
As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to ...
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