Webinar | Navigating FDA Compliance: Defining Your QMSR Journey
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EMDN MDCG 2025 Update: New Guidance for Medical Devices
The EMDN MDCG 2025 update has been released, incorporating feedback from the 2024 Public Consultation and the MDCG Nomenclature Working…
Swiss Medtech: Net-Zero Roadmap for Medical Device Firms
As of January 2024, The Climate and Innovation Act (KIG) has officially come into force, setting a clear pathway for…
Australia 2024 Update: Market Authorization for Medical Devices
An update to Australia’s guidance on the use of market authorization evidence from overseas regulators for medical devices, including in-vitro…
EU Cosmetics Regulation 2024: New Ingredient Restrictions
On April 3, 2024, the European Commission adopted Regulation (EU) 2024/996, bringing further amendments to the Cosmetics Regulation (No. 1223/2009).
US Medical Device Market Entry: Key Strategies and Burdens
Responsible for approximately 50% of the estimated USD 578.75 billion global medical device market (in 2024), North America continues…
Key Global Markets for US Medical Device Manufacturers
For US medical device manufacturers considering non-US markets, understanding the influence of North America’s dominant medical device landscape and…
New Modifications on Vigilance Terms from MDCG
MDCG has made minor modifications to the MDCG 2023-3 guidance, “Questions and Answers on vigilance terms and concepts…
FDA Draft Guidance on AI-Enabled Device Submissions
The FDA has issued their draft recommendations (January 2025), regarding the content of marketing submissions for medical devices that…
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