Sep — 2023 Update to FDA Guidance Use of International Standard ISO 10993-1 and Biocompatibility of Devices in Contact with Intact Skin By: Read Article
Jul — 2023 Challenges within the European MedTech Market: How MCRA’s Experts Stand Out Written by: Peter Bowness, Vice President, Regulatory Affairs & Operations - Europe Read Article
Jul — 2023 UKCA and CE Transitions for IVD Medical Devices: Planning is Key The EU and UK are both under a period of legislative change for In Vitro Diagnostic (IVD) medical devices. By: Erica Conway, Vic Read Article
Feb — 2018 The Impact of U.S. Regulation on Medical Device Innovation Passion, inspiration, perseverance, altruism, and need have historically been the factors driving innovators. read article
Jan — 2018 Sanuwave Receives FDA De Novo Decision to Immediately Market the Dermapace System for the Treatment of Diabetic Foot Ulcers in the U.S. SUWANEE, GA, Jan. 02, 2018 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (OTCQB: SNWV) has announced that the U.S. read article
May — 2017 Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel For a company navigating a Class III medical device’s path to market, the U.S. read article