Medical Devices February 16, 2023 Elexes Team Common pitfalls during the CE marking of a Medical Device or IVD Read More Post a Comment
Elexes Blog February 16, 2023 Elexes Team LDTs vs. IVDs: Understanding FDA’s New Guidelines and Their Impact Read More Post a Comment
Medical Devices December 2, 2022 Elexes Team All you need to know about a Premarket Approval (PMA) Submission — Route to the US Market for Class III medical devices Read More Post a Comment
Medical Devices September 30, 2022 Elexes Team A to Z of a Clinical Evaluation Report Read More Post a Comment
Medical Devices September 30, 2022 Elexes Team EU Classifications and Rules for CE Marking Read More Post a Comment
Medical Devices September 30, 2022 Elexes Team The US FDA Medical Device User Fee for the Fiscal Year 2022 Read More Post a Comment
Medical Devices September 30, 2022 Elexes Team ISO 15223-1:2021 Medical Device Symbols – An indispensable part of labeling Read More Post a Comment
Medical Devices September 30, 2022 Elexes Team BS EN ISO 13485:2016/A11:2021 Read More Post a Comment
Medical Devices September 30, 2022 Elexes Team What does CE Marking imply and why is it required? Read More Post a Comment
Medical Devices September 30, 2022 Elexes Team FDA’s New Requirements: What the MR based Medical Device Manufacturers need to know Read More Post a Comment