Medical Devices June 24, 2024 Vaishali Predicate Device: What is it and How to Choose the Right One? Read More Post a Comment
Medical Devices June 19, 2024 Elexes Team FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours Read More Post a Comment
Medical Devices June 17, 2024 Elexes Team Different types of 510k submissions | Special, Abbreviated vs Traditional 510(k) Read More Post a Comment
Medical Devices February 2, 2024 Elexes Team 510(k) Clearance | Recommendation Ensuring Minimal Delay! Read More Post a Comment
News September 18, 2023 Elexes Team FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications! Read More Post a Comment
Medical Devices August 14, 2023 Elexes Team 510K Submission | How To Pass Through FDA’s “Refuse to Accept” Policy! Read More Post a Comment
Medical Devices June 8, 2023 Elexes Team Top 5 Common Mistakes to Avoid in the 510(k) Submission Read More Post a Comment
Medical Devices February 16, 2023 Elexes Team Refuse to Accept – An important milestone for your device during the FDA review process Read More Post a Comment
Medical Devices June 22, 2021 Elexes Team Modernization of 510(k) – A major milestone to safer and better healthcare Read More Post a Comment
Medical Devices June 15, 2021 Elexes Team Is your medical device 510(k) exempt? Understanding the classification of medical devices! Read More Post a Comment