Notícias

Instituto Pedro Nunes‘ Medical Devices Regulatory — support unit participated in the presentation of TEF-Health and DigiHealthPT projects and their respective service catalogues, in Lisbon.Through these projects, our team specializes in assisting SMEs and start-ups with regulatory compliance and supporting the certification of medical devices, IVDs, and medical software. We understand the complexities of regulatory requirements and are committed to supporting you throughout the process, ensuring your innovations reach the market quickly and efficiently.TEF-Health aims to build TEF (Testing and Experimental Facilities) structures, establishing a vital link between companies and hospitals. As well as providing environments for testing and demonstrating solutions, the TEFs will facilitate ethical and data protection reviews, integrating activities such as incubation and market analyses.DigiHealthPT is a Digital Innovation Hub, part of the European DIH Network, which focuses on the application of Artificial Intelligence and Cybersecurity in Health to respond to the emerging needs of startups, SMEs, and the public sector, supporting digital innovation and promoting the adoption of digital solutions.

Important Update in EU Medical Device Regulation In January 2024, the medical device community is greeted with updated guidance from the Medical Device Coordination Group (MDCG). The latest release, MDCG 2024-1-2, specifically focuses on the vigilance system for CE-marked devices, with a keen eye on Coronary Stents and their associated delivery systems under DSVG 02. Know more about our Post Market Surveillance (PMS) services at https://lnkd.in/dt4tQYNy

Attention healthcare innovators! Ready to spearhead change in the healthcare sector? The EIT Health Regulatory Pathways to Market Bootcamp is your ticket to success! With 8 hours of mentoring with experts and 60 hours of immersive content, this bootcamp offers an opportunity to tackle regulatory challenges and accelerate your company’s growth. The top 10 ranked companies will receive an exclusive 50% discount on participation fees!