Start-ups in the medtech space face many challenges on the way to market, not the least of which is how to prepare for, and comply with, medical device regulations. Here are some points to consider.

The 510(k) pathway is one of several regulatory pathways by which medical devices, including those with breakthrough designations, can receive marketing authorization from the FDA.

Malaysia has made historic advancement in international regulatory collaboration with the launch of the Medical Device Regulatory Reliance Programme between the country and China. Medical Device ...

Master market access for medical device software with our expert-led course. Navigate international regulations, understand reimbursement pathways, a Tuesday, 02 January 2024 12:17 GMT ...

As the medical device industry continues to expand, intellectual property (IP) considerations — especially those concerning ...

- Regulatory alignment with FDA confirmed, clearing path to pivotal U.S. clinical trial -- 150-page strategic business plan and advanced financial models completed -- Investor outreach launched to ...

DeepView AI ®- Burn, which received Breakthrough Device Designation from the U.S. Food and Drug Administration in 2018, is a predictive medical device that assesses the healing potential of burns ...

South Korea’s medical device market is rapidly expanding, driven by technological innovations and increasing healthcare demands. As the market grows, understanding Korean medical device regulations is ...

FDA Perspectives and Regulatory Pathways for AI-Enabled Cardiovascular Devices. Presenter: Stephen Browning. October 30, 2024. REGISTER for free or LOG IN to view this content. Policy & Practice. TCT ...

Appraisers can now become trained and certified in the Medical Device Discovery Appraisal Program (MDDAP) through a mix of coursework, observations and apprenticeships MDDAP is empowering ...

Master market access for medical device software with our expert-led course. Navigate international regulations, understand reimbursement pathways, and enhance commercial success globally. Gain ...