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News

FDA finalizes computer software assurance guidance for production and quality system software

29 September 2025

Insights and Analysis

Shifting Borders, Securing Quality: Strategic Insights for Medical Device Companies Navigating Supplier Controls Through Near-Shoring and Friend-Shoring

26 September 2025

News

Section 232 tariff investigation: What medical device manufacturers and importers need to know

26 September 2025

Insights and Analysis

FDA enforcement against SeniorLife, Whoop signal new line in the sand for AI health apps

19 September 2025

News

FDA medical device inspections in 2025: What we're seeing, what we expected, and why you need the right expertise now

18 September 2025

News

Supreme People’s Court intensifies crackdown on medical insurance fraud: Strategic implications for legal and compliance teams

22 August 2025

News

California’s new climate disclosure laws: Implications for the life sciences and health care sector

18 August 2025

News

FDA updates medical device user fee guidance for small businesses, tightening some rules for reductions and waivers

15 August 2025

News

Key takeaways – UK MHRA’s response to consultation on ‘Medical Devices Regulations: Routes to market and in vitro diagnostic devices’

05 August 2025

Insights and Analysis

China’s healthcare compliance guidelines: insights and actionable steps for life sciences companies

29 July 2025

Insights and Analysis

China’s 2025 Anti-Unfair Competition Law Revision: A new era of enforcement and accountability

25 July 2025

Insights and Analysis

China announces new restrictions on the participation of certain EU-origin medical devices in government procurement activities

18 July 2025

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